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NCT00299130 · OUTCOME

Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48

A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis · Source last updated 2017-04-17

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 and Week 48

What was measured

A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: * an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, * an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of 5.1 or higher.

Analysis population: Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Patients who withdrew prior to week 48, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.

Groups in this outcome

Placebo + MTX

Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.

Rituximab 2 x 0.5 g + MTX

Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.

Rituximab 2 x 1.0 g + MTX

Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.

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 + MTX172
Rituximab 2 x 0.5 g + MTX167
Rituximab 2 x 1.0 g + MTX170

Reported measurements

No Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + MTX41.3Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 0.5 g + MTX26.9Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 1.0 g + MTX31.8Not reportedNot reportedNot reportedNot reported
Moderate Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + MTX41.9Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 0.5 g + MTX53.3Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 1.0 g + MTX47.6Not reportedNot reportedNot reportedNot reported
Good Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + MTX16.9Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 0.5 g + MTX19.8Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 1.0 g + MTX20.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        41.3
      2. group Id
        OG001
        value
        26.9
      3. group Id
        OG002
        value
        31.8
    title
    No Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        41.9
      2. group Id
        OG001
        value
        53.3
      3. group Id
        OG002
        value
        47.6
    title
    Moderate Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16.9
      2. group Id
        OG001
        value
        19.8
      3. group Id
        OG002
        value
        20.6
    title
    Good Response
denoms
  1. counts
    1. group Id
      OG000
      value
      172
    2. group Id
      OG001
      value
      167
    3. group Id
      OG002
      value
      170
    units
    Participants
description
A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: * an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, * an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of 5.1 or higher.
groups
  1. description
    Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    OG000
    title
    Placebo + MTX
  2. description
    Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    OG001
    title
    Rituximab 2 x 0.5 g + MTX
  3. description
    Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
    id
    OG002
    title
    Rituximab 2 x 1.0 g + MTX
param Type
NUMBER
population Description
Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Patients who withdrew prior to week 48, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders.
reporting Status
POSTED
time Frame
Baseline and Week 48
title
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice