NCT00299104 · OUTCOME

Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52

A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis · Source last updated 2017-07-28

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

Measure: MEAN
Unit: Score on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline and week 52

What was measured

Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.

Analysis population: Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.

Groups in this outcome

Placebo + Methotrexate

Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.

Rituximab (0.5 g x 2) + Methotrexate

Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6

Rituximab (1.0 g x 2) + Methotrexate

Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6

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 + Methotrexate	232
Rituximab (0.5 g x 2) + Methotrexate	239
Rituximab (1.0 g x 2) + Methotrexate	244

Reported measurements

Source class 1

Values in Score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Methotrexate	1.079	4.0934	Not reported	Not reported	Not reported
Rituximab (0.5 g x 2) + Methotrexate	0.646	1.9196	Not reported	Not reported	Not reported
Rituximab (1.0 g x 2) + Methotrexate	0.359	1.0095	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Pct Value
95
group Description
Comparing all three treatment groups
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0016
p Value Comment
The Closure Principle was used to adjust for multiple comparisons.
statistical Method
Kruskal-Wallis
ci Pct Value
95
group Description
Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1824
p Value Comment
The Closure Principle was used to adjust for multiple comparisons.
statistical Method
Van-Elteren
ci Pct Value
95
group Description
Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0004
p Value Comment
The Closure Principle was used to adjust for multiple comparisons.
statistical Method
Van-Elteren

Complete source fields

analyses

ci Pct Value
95
group Description
Comparing all three treatment groups
group Ids
OG000
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0016
p Value Comment
The Closure Principle was used to adjust for multiple comparisons.
statistical Method
Kruskal-Wallis
ci Pct Value
95
group Description
Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.1824
p Value Comment
The Closure Principle was used to adjust for multiple comparisons.
statistical Method
Van-Elteren
ci Pct Value
95
group Description
Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.0004
p Value Comment
The Closure Principle was used to adjust for multiple comparisons.
statistical Method
Van-Elteren

classes

categories
measurements
group Id
OG000
spread
4.0934
value
1.079
group Id
OG001
spread
1.9196
value
0.646
group Id
OG002
spread
1.0095
value
0.359

denoms

counts
group Id
OG000
value
232
group Id
OG001
value
239
group Id
OG002
value
244
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.
id
OG000
title
Placebo + Methotrexate
description
Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
id
OG001
title
Rituximab (0.5 g x 2) + Methotrexate
description
Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
id
OG002
title
Rituximab (1.0 g x 2) + Methotrexate

param Type

MEAN

population Description

Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.

reporting Status

POSTED

time Frame

Baseline and week 52

title

Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52

type

PRIMARY

unit Of Measure

Score on a scale

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Preserved source evidence · Not medical advice