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NCT00299130 · OUTCOME

Percent Change From Baseline in C-Reactive Protein

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
MEAN
Unit
percent change
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 24 and Week 48

What was measured

C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.

Analysis population: Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point.

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

Week 24 [N=172, 166, 170]
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo + MTX58.1385.23Not reportedNot reportedNot reported
Rituximab 2 x 0.5 g + MTX-27.584.36Not reportedNot reportedNot reported
Rituximab 2 x 1.0 g + MTX-23.1119.75Not reportedNot reportedNot reported
Week 48 [N=172, 166, 170]
Values in percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo + MTX40.1402.67Not reportedNot reportedNot reported
Rituximab 2 x 0.5 g + MTX-37.394.65Not reportedNot reportedNot reported
Rituximab 2 x 1.0 g + MTX-34.982.40Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        385.23
        value
        58.1
      2. group Id
        OG001
        spread
        84.36
        value
        -27.5
      3. group Id
        OG002
        spread
        119.75
        value
        -23.1
    title
    Week 24 [N=172, 166, 170]
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        402.67
        value
        40.1
      2. group Id
        OG001
        spread
        94.65
        value
        -37.3
      3. group Id
        OG002
        spread
        82.40
        value
        -34.9
    title
    Week 48 [N=172, 166, 170]
denoms
  1. counts
    1. group Id
      OG000
      value
      172
    2. group Id
      OG001
      value
      167
    3. group Id
      OG002
      value
      170
    units
    Participants
description
C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation. The percentage change from baseline at each post-baseline visit was calculated as: \[(post-baseline value minus baseline value) divided by Baseline value\]\*100. A negative percentage change from baseline score indicates an improvement.
dispersion Type
Standard Deviation
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
MEAN
population Description
Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point.
reporting Status
POSTED
time Frame
Baseline, Week 24 and Week 48
title
Percent Change From Baseline in C-Reactive Protein
type
SECONDARY
unit Of Measure
percent change

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Preserved source evidence · Not medical advice