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NCT00299130 · OUTCOME

Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score

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
scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 24 and Week 48

What was measured

The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement.

Analysis population: Intent-to-treat population. "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=137, 153, 156]
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo + MTX3.2788.6850Not reportedNot reportedNot reported
Rituximab 2 x 0.5 g + MTX2.7709.9943Not reportedNot reportedNot reported
Rituximab 2 x 1.0 g + MTX4.4869.4930Not reportedNot reportedNot reported
Week 48 [N=135, 147, 147]
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo + MTX3.8908.7493Not reportedNot reportedNot reported
Rituximab 2 x 0.5 g + MTX4.58310.5625Not reportedNot reportedNot reported
Rituximab 2 x 1.0 g + MTX4.2249.9831Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.6850
        value
        3.278
      2. group Id
        OG001
        spread
        9.9943
        value
        2.770
      3. group Id
        OG002
        spread
        9.4930
        value
        4.486
    title
    Week 24 [N=137, 153, 156]
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.7493
        value
        3.890
      2. group Id
        OG001
        spread
        10.5625
        value
        4.583
      3. group Id
        OG002
        spread
        9.9831
        value
        4.224
    title
    Week 48 [N=135, 147, 147]
denoms
  1. counts
    1. group Id
      OG000
      value
      172
    2. group Id
      OG001
      value
      167
    3. group Id
      OG002
      value
      170
    units
    Participants
description
The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive 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. "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
Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice