NCT00468546 · OUTCOME

Percentage of Participants Without Erosive Progression

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy · Source last updated 2016-10-25

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: Up to Week 104

What was measured

The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage and negative change score indicates improvement.

Analysis population: ITT population included all randomized participants who received any part of an infusion of study medication. Participants with available data at the time of evaluation were analyzed.

Groups in this outcome

Placebo Plus Methotrexate

Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.

Rituximab Plus Methotrexate

Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.

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
Placebo Plus Methotrexate	187
Rituximab Plus Methotrexate	281

Reported measurements

Baseline to Year 1, n = 186, 278

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo Plus Methotrexate	51	Not reported	Not reported	Not reported	Not reported
Rituximab Plus Methotrexate	66	Not reported	Not reported	Not reported	Not reported

Year 1 to Year 2, n = 186, 278

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo Plus Methotrexate	58	Not reported	Not reported	Not reported	Not reported
Rituximab Plus Methotrexate	73	Not reported	Not reported	Not reported	Not reported

Baseline to Year 2, n = 187, 281

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo Plus Methotrexate	44	Not reported	Not reported	Not reported	Not reported
Rituximab Plus Methotrexate	60	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
51
group Id
OG001
value
66
title
Baseline to Year 1, n = 186, 278
categories
measurements
group Id
OG000
value
58
group Id
OG001
value
73
title
Year 1 to Year 2, n = 186, 278
categories
measurements
group Id
OG000
value
44
group Id
OG001
value
60
title
Baseline to Year 2, n = 187, 281

denoms

counts
group Id
OG000
value
187
group Id
OG001
value
281
units
Participants

description

groups

description
Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
id
OG000
title
Placebo Plus Methotrexate
description
Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
id
OG001
title
Rituximab Plus Methotrexate

param Type

NUMBER

population Description

ITT population included all randomized participants who received any part of an infusion of study medication. Participants with available data at the time of evaluation were analyzed.

reporting Status

POSTED

time Frame

Up to Week 104

title

Percentage of Participants Without Erosive Progression

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice