NCT00266227 · OUTCOME

Change From Baseline in American College of Rheumatology (ACR) Core Set Component: C-Reactive Protein at Week 48

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate · Source last updated 2013-10-25

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

Measure: MEAN
Unit: mg/dL
Interval / dispersion: Standard Deviation
Time frame: Baseline, Week 48

What was measured

Blood was collected for C-Reactive Protein, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.

Analysis population: Intent-to-treat Population includes all participants randomized to Retreatment.

Groups in this outcome

Arm A: Rituximab Retreatment

1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.

Arm B: Placebo Retreatment

1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Arm A: Rituximab Retreatment	318
Arm B: Placebo Retreatment	157

Reported measurements

Source class 1

Values in mg/dL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm A: Rituximab Retreatment	-0.8	2.55	Not reported	Not reported	Not reported
Arm B: Placebo Retreatment	-0.6	2.95	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
2.55
value
-0.8
group Id
OG001
spread
2.95
value
-0.6

denoms

counts
group Id
OG000
value
318
group Id
OG001
value
157
units
Participants

description

Blood was collected for C-Reactive Protein, an inflammatory marker, at Baseline and Week 48. A negative change from baseline indicates improvement.

dispersion Type

Standard Deviation

groups

description
1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
id
OG000
title
Arm A: Rituximab Retreatment
description
1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
id
OG001
title
Arm B: Placebo Retreatment

param Type

MEAN

population Description

Intent-to-treat Population includes all participants randomized to Retreatment.

reporting Status

POSTED

time Frame

Baseline, Week 48

title

Change From Baseline in American College of Rheumatology (ACR) Core Set Component: C-Reactive Protein at Week 48

type

SECONDARY

unit Of Measure

mg/dL

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

Preserved source evidence · Not medical advice