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NCT00299130 · OUTCOME

Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission 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
Week 48

What was measured

The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * Erythrocyte sedimentation rate (ESR); * Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6.

Analysis population: Intent to treat population including participants with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.

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 + MTX171
Rituximab 2 x 0.5 g + MTX165
Rituximab 2 x 1.0 g + MTX169

Reported measurements

Low Disease Activity
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + MTX18.1Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 0.5 g + MTX20.0Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 1.0 g + MTX24.3Not reportedNot reportedNot reportedNot reported
Clinical Remission
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + MTX7.0Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 0.5 g + MTX9.1Not reportedNot reportedNot reportedNot reported
Rituximab 2 x 1.0 g + MTX11.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18.1
      2. group Id
        OG001
        value
        20.0
      3. group Id
        OG002
        value
        24.3
    title
    Low Disease Activity
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7.0
      2. group Id
        OG001
        value
        9.1
      3. group Id
        OG002
        value
        11.2
    title
    Clinical Remission
denoms
  1. counts
    1. group Id
      OG000
      value
      171
    2. group Id
      OG001
      value
      165
    3. group Id
      OG002
      value
      169
    units
    Participants
description
The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * Erythrocyte sedimentation rate (ESR); * Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6.
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 including participants with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing.
reporting Status
POSTED
time Frame
Week 48
title
Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice