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NCT00282308 · OUTCOME

Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24

A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate · Source last updated 2017-08-10

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

Measure
NUMBER
Unit
Percentage of patients
Interval / dispersion
Not reported
Time frame
Week 24

What was measured

Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" \[symptom-free and no arthritis symptoms\] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.

Analysis population: Safety population: All patients who received any amount of rituximab or any vaccine. Since only limited efficacy data were collected in this study, the parameters necessary to calculate the ACR20/50/70 responses were only available for patients in Group A.

Groups in this outcome

Rituximab + Methotrexate (Group A)

Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during 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
Rituximab + Methotrexate (Group A)66

Reported measurements

ACR 20%
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)36.4Not reportedNot reportedNot reportedNot reported
ACR 50%
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)21.2Not reportedNot reportedNot reportedNot reported
ACR 70%
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rituximab + Methotrexate (Group A)4.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        36.4
    title
    ACR 20%
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21.2
    title
    ACR 50%
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4.5
    title
    ACR 70%
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    units
    Participants
description
Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" \[symptom-free and no arthritis symptoms\] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.
groups
  1. description
    Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
    id
    OG000
    title
    Rituximab + Methotrexate (Group A)
param Type
NUMBER
population Description
Safety population: All patients who received any amount of rituximab or any vaccine. Since only limited efficacy data were collected in this study, the parameters necessary to calculate the ACR20/50/70 responses were only available for patients in Group A.
reporting Status
POSTED
time Frame
Week 24
title
Percentage of Patients in Group A With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
type
SECONDARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice