SMART Study: A Study of Re-treatment With MabThera (Ritux... | NCT01126541

Label	Type	Description	Intervention Names
A	Experimental	1000 mg IV rituximab	Drug: rituximab
B	Experimental	2 x 1000 mg IV rituximab	Drug: rituximab

Name	Type	Description	Arm Group Labels	Other Names
rituximab	Drug	Arm A: 1000 mg IV (one infusion) every 2 months \nArm B: 2 x 1000 mg IV (2 infusions) every 2 months	A B

Measure	Description	Time Frame
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS28-CRP) Area Under the Curve (AUC) at Week 104	DAS28-CRP was based on joint counts, overall participant assessment, and serum CRP levels (measured in milligrams per liter [mg/L]) at each visit. Joint counts included swollen joint count (SJC) and tender joint count (TJC). Total score range was 0 to 9.4; a higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and less than (<)2.6 equals (=) remission. The AUC of all DAS28-CRP values between Day 1 and Week 104 (15 values of protocol visits) was calculated using the trapeze method (AUC between t1 and t2=(t2-t1)*((DAS28-CRP at t1 + DAS28-CRP at t2)/2). The true visit dates were used to calculate the time between 2 DAS28-CRP evaluations. All the AUC were censored at Week 104 (linear extrapolation using the 2 last DAS28-CRP values (Weeks 96 and 104) to obtain the "true" DAS28-CRP value at the "true" Week 104).	Week 104

Measure	Description	Time Frame
DAS28-CRP During the Initial Treatment	Mean DAS28-CRP at Week 24 of the Initial Treatment study. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Chair

PubMed Identifier	Type	Citation	Retractions
28363827	Derived	de Jong TD, Sellam J, Agca R, Vosslamber S, Witte BI, Tsang-A-Sjoe M, Mantel E, Bijlsma JW, Voskuyl AE, Nurmohamed MT, Verweij CL, Mariette X. A multi-parameter response prediction model for rituximab in rheumatoid arthritis. Joint Bone Spine. 2018 Mar;85(2):219-226. doi: 10.1016/j.jbspin.2017.02.015. Epub 2017 Mar 28.
27964756

ID	Title	Description
FG000	Randomized Retreatment Arm A: Rituximab 1000 Milligrams (mg)	Participants received rituximab 1000 mg intravenously (IV) on Days 1 and 15. After Week 24, if Disease Activity Score based on 28-Joint Count (DAS28) was greater than (>)3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and methotrexate (MTX) ≥10 milligrams per week (mg/week) by mouth or parenteral throughout course of treatment.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Secondary

DAS28-CRP During the Initial Treatment

Mean DAS28-CRP at Week 24 of the Initial Treatment study. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.

Overall population: all participants with at least one treatment intake.

Posted

Mean

Standard Deviation

units on a scale

Days 1 and 15, and Weeks 6, 12, and 24

ID	Title	Description
OG000	Randomized Group	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Nonrandomized Group	Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.

Units	Counts
Participants	OG000143 OG00181

Title

Denominators

Categories

First Course, Day 1

Title	Measurements
	OG0005.82± 0.85 OG0015.77± 0.90

First Course, Day 15

Title	Measurements
	OG000

Secondary

DAS28-CRP and Changes From Baseline to Week 24 in DAS28-CRP by Retreatment Course

DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and <2.6=remission.

ITT Population; number (n)=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

units on a scale

Day 1, 24 weeks following each infusion up to 72 Weeks

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Primary

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS28-CRP) Area Under the Curve (AUC) at Week 104

DAS28-CRP was based on joint counts, overall participant assessment, and serum CRP levels (measured in milligrams per liter [mg/L]) at each visit. Joint counts included swollen joint count (SJC) and tender joint count (TJC). Total score range was 0 to 9.4; a higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity, and less than (<)2.6 equals (=) remission. The AUC of all DAS28-CRP values between Day 1 and Week 104 (15 values of protocol visits) was calculated using the trapeze method (AUC between t1 and t2=(t2-t1)*((DAS28-CRP at t1 + DAS28-CRP at t2)/2). The true visit dates were used to calculate the time between 2 DAS28-CRP evaluations. All the AUC were censored at Week 104 (linear extrapolation using the 2 last DAS28-CRP values (Weeks 96 and 104) to obtain the "true" DAS28-CRP value at the "true" Week 104).

Per Protocol (PP) population: all randomized participants in the Intent-to-Treat (ITT) population (defined as all randomized participants) without major protocol violations. Participants were grouped according to their initially assigned treatment arm irrespective of the treatment actually received.

Posted

Mean

Standard Error

score on a scale*week

Week 104

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.

Secondary

Percentage of Participants Achieving Clinical Remission (DAS28-CRP <2.6) or Low Disease Activity (DAS28-CRP ≤3.2)

Percentage of participants with clinical remission and low disease activity as measured by DAS28-CRP for Arm A and Arm B at Week 24 of the Initial Treatment, at 24 weeks after first re-treatment, and at 24 weeks after second retreatment. DAS28-CRP was based on joint counts, overall participant assessment, and the serum CRP level at each visit. Joint counts included SJC and TJC using the 28 joints count and CRP (mg/L). Total score range=0 to 9.4; a higher score indicated more disease activity. A DAS28-CRP score of ≤3.2 implied low disease activity and <2.6 = remission.

ITT Population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Number

percentage of participants

Week 24 of the Initial Treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

DAS28-CRP AUC Weighted Time

ITT population

Posted

Mean

Standard Deviation

units on a scale*week

Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Time to Achieve DAS28-CRP Remission After the First Course

ITT population

Posted

Median

95% Confidence Interval

weeks

Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104

ID	Title	Description
OG000	Randomized Group	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.

Units	Counts
Participants	OG000

Secondary

Time to Achieve DAS28-CRP Remission After Retreatment

ITT population; n=number of participants assessed at a given visit.

Posted

Median

95% Confidence Interval

weeks

Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Time to Achieve DAS28-CRP ≤3.2 After the First Course of Treatment

ITT population

Posted

Median

95% Confidence Interval

weeks

Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104

ID	Title	Description
OG000	Randomized Group	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.

Units	Counts
Participants	OG000

Secondary

Time to Achieve DAS28-CRP ≤3.2 After Retreatment

ITT population; n=number of participants assessed at a given visit.

Posted

Median

95% Confidence Interval

weeks

Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Duration of DAS28-CRP Remission After the First Course of Treatment

ITT population; only participants with a response (DAS28-CRP <2.6) during initial treatment (at any point) were included in the analysis.

Posted

Median

95% Confidence Interval

weeks

Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104

ID	Title	Description
OG000	Randomized Group	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.

Units	Counts
Participants	OG000

Secondary

Duration of DAS28-CRP Remission After Retreatment

ITT population; only participants with a response (DAS28-CRP <2.6) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.

Posted

Median

95% Confidence Interval

weeks

Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Duration of DAS28-CRP ≤3.2 After the First Course of Treatment

ITT population; only participants with a response (DAS28-CRP ≤3.2) during first course of treatment (at any point) were included in the analysis.

Posted

Median

95% Confidence Interval

weeks

Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104

ID	Title	Description
OG000	Randomized Group	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.

Units	Counts
Participants	OG000

Secondary

Duration of DAS28-CRP ≤3.2 After Retreatment

ITT population; only participants with a response (DAS28-CRP ≤3.2) during retreatment (at any point) were included in the analysis. n=number of participants assessed at a given visit.

Posted

Median

95% Confidence Interval

weeks

Days 1 and 15, Weeks 6, 12, and 24 and every 8 weeks thereafter through Week 104

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Percentage of Participants Achieving American College of Rheumatology 20%, 50%, and 70% Improvement (ACR20/ACR50/ACR70)

ACR20/50/70 response defined as ≥20%, 50%, or 70% improvement, respectively, in TJC and SJC, and ≥20%, 50%, or 70% improvement, respectively, in at least 3 of 5 remaining ACR core measures: Patient Global Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity (on a visual analog scale [VAS]); Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP.

ITT Population

Posted

Number

percentage of participants

Week 24 of the initial treatment, 24 weeks after first retreatment, and 24 weeks after second retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Percentage of Participants Achieving a Response During Initial Treatment by European League Against Rheumatism (EULAR) Category

DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders = change from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = change from baseline >1.2 with a DAS28 score of >3.2 to ≤ 5.1 or change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = change from baseline ≤0.6 or change from baseline >0.6 and ≤ 1.2 with a DAS28 score of >5.1.

Overall population

Posted

Number

percentage of participants

Day 15, Weeks 6, 12, and 24

ID	Title	Description
OG000	Randomized Group	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Nonrandomized Group	Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.

Secondary

Percentage of Participants Achieving a Response During Retreatment by EULAR Category

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Number

percentage of participants

Week 24, 24 weeks after 1st retreatment, 24 weeks after 2nd retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Percentage of Participants With Rheumatoid Factor (RF) at 24 Weeks After Treatment

RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 international units per milliliter (IU/mL) is considered positive.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Number

percentage of participants

Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Percentage of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at 24 Weeks After Treatment

Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Number

percentage of participants

Week 24 of the initial treatment, 24 weeks after first re-treatment, and 24 weeks after second retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Physician's Global Assessment of Disease Activity

The Physician's Global Assessment of disease activity is assessed on a 0 to 100 millimeter (mm) horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). Physicians were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high disease activity).

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Patient Global Assessment of Disease Activity

The Patient's Global Assessment of Disease Activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Re-treatment Arm A: Single 1000 mg IV Rituximab	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Patient's Global Assessment of Pain

The participants assessed their pain over the past 24 hours on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high pain levels).

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Participant Assessment of Fatigue

Participants were asked to rate their level of fatigue over the last 7 days on a 100-mm VAS. The left-hand extreme of the line equals 0 mm, and is described as "no fatigue" and the right-hand extreme equals 100 mm as "extreme fatigue". Participants were asked to mark the line and the distance from the left edge was measured. Higher values correspond to worst state of participant (high levels of fatigue).

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Cortisone Intake AUC (Time- and Weight-Weighted)

All cortisone intakes (in mg) were taken into account (oral, IV [including the cortisone administration before the rituximab infusion], intramuscular, and intra-articular).

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Error

mg*week

Day 1 (each infusion), Week 24, Week 104

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Total Mean Dose of Cortisone Between Week 24 and Week 104

All cortisone intakes were taken into account, including oral, IV (including the cortisone administration before the rituximab infusion), intramuscular and intra-articular.

ITT population

Posted

Mean

Standard Deviation

Week 24 to Week 104

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Units	Counts

Secondary

HAQ-DI Scores

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

units on a scale

Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Short Form 12 (SF-12) Physical Health Composite Score

Physical and Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

units on a scale

Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

SF-12 Mental Health Composite Score

Mental Health Composite Scores of SF-12 were computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

units on a scale

Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Medical Outcomes Study Sleep Scale (MOS-Sleep) Composite Sleep Problems 6 (SLP6) Index

The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The SLP6 index is comprised of 6 items: provides a summary of sleep problems and contains questions from the sleep disturbance, sleep adequacy, respiratory impairment, and somnolence domains. The SLP6 index score ranges between 0 and 100, with higher values corresponding to more sleep problems.

ITT population;n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

units on a scale

Day 1 and Week 24 of initial treatment, before 1st retreatment, at 1st retreatment, and at 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Percentage of Participants Reporting Acceptable Disease Activity Symptom State Assessed Using Patient Acceptable and Unacceptable Symptom State (PASS)

Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of disease activity they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered "unacceptable".

ITT population

Posted

Number

percentage of participants

Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Patient Global Assessment of Disease Activity in Participants Reporting Acceptable Symptoms Using PASS

The Patient's Global Assessment of Disease Activity assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).

ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2

Secondary

Percentage of Participants With Minimum Clinically Important Improvement (MCII) in Disease Activity

Participants were asked how their disease activity had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse-more disease activity.

ITT population

Posted

Number

percentage of participants

Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Change From Baseline in Patient Global Assessment of Disease Activity in Participants With MCII

The Patient's Global Assessment of Disease Activity was assessed in participants reporting MCII on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).

ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

Baseline, Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Percentage of Participants Reporting Acceptable Symptom State in Functioning Assessed Using PASS

Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of function they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of function they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered "unacceptable".

ITT population

Posted

Number

percentage of participants

Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

HAQ-DI Scores in Participants Reporting Acceptable Function Using PASS

HAQ-DI was assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of disease activity they had during the last 48 hours). HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.

ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

units on a scale

Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2

Secondary

Percentage of Participants With MCII in Functioning

Participants were asked how their functioning had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse.

ITT population

Posted

Number

percentage of participants

Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Change From Baseline in HAQ-DI in Participants With MCII

HAQ-DI was assessed in participants with MCII. HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3 extreme difficulty.

ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Percentage of Participants With Acceptable Symptom State in Pain Assessed Using PASS

Percentage of participants reporting acceptable symptom state: acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours; and unacceptable symptom state: not able to remain for the rest of their lives with the level of pain they had during the last 48 hours. In the case of missing data, participants who withdrew from the study because of inefficacy or toxicity were considered "unacceptable".

ITT population

Posted

Number

percentage of participants

Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Patient Global Assessment of Pain in Participants Reporting Acceptable Symptoms Using PASS

Patient Global Assessment of Pain assessed in participants reporting acceptable symptom state using PASS (acceptance to remain for the rest of their lives with the level of pain they had during the last 48 hours) on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". Higher values correspond to worst state of participant (high pain levels).

ITT population; only participants with 'acceptable' symptom state assessed using PASS were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Percentage of Participants With MCII in Pain

Participants were asked how their pain had been during the last 48 hours compared to baseline. Those participants that reported improvement assessed how important this improvement was to them; range: very important, moderately important, slightly important, or not at all important. Binary response options: 1=improved very important, or improved moderately important; 2=slightly important, not at all important, no change, or worse pain.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Posted

Number

percentage of participants

Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Secondary

Change From Baseline in Patient Global Assessment of Pain in Participants With MCII

ITT population; only participants with MCII were included in the analysis. n=number of participants assessed for the specified parameter at a given visit.

Posted

Mean

Standard Deviation

Baseline, Week 24, 12 and 24 weeks after 1st retreatment

ID	Title	Description
OG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
OG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG00013 affected66 at risk EG00116 affected68 at risk EG00211 affected81 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0009 affected66 at risk EG00112 affected68 at risk EG00214 affected81 at risk
Gastroenteritis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0008 affected66 at risk EG00110 affected68 at risk EG0023 affected81 at risk
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0007 affected66 at risk EG0016 affected68 at risk EG0022 affected81 at risk
Rhinitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected66 at risk EG0014 affected68 at risk EG0026 affected81 at risk
Pharyngitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected66 at risk EG0016 affected68 at risk EG0022 affected81 at risk
Tonsillitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected66 at risk EG0013 affected68 at risk EG0020 affected81 at risk
Sinusitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Influenza	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected66 at risk EG0013 affected68 at risk EG0020 affected81 at risk
Oral herpes	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected68 at risk EG0022 affected81 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0013 affected68 at risk EG0020 affected81 at risk
Bronchopneumonia	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Fungal skin infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Localised infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Tracheitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Acute sinusitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Cystitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Fungal infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Onychomycosis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Oral fungal infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Rhinotracheitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Sinobronchitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Abdominal wall abscess	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Bronchiectasis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Bursitis infective	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Campylobacter intestinal infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Chronic sinusitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Ear infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Folliculitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Hepatitis B	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Hordeolum	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Infected sebaceous cyst	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Laryngitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Lung infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Otitis externa	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Perianal abscess	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Pertussis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Prostate infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Skin infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Tinea pedis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Tinea versicolour	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Tooth infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Vaginal candidiasis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Vaginal infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Viral infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0008 affected66 at risk EG00112 affected68 at risk EG0028 affected81 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00010 affected66 at risk EG00110 affected68 at risk EG0023 affected81 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0016 affected68 at risk EG0023 affected81 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0015 affected68 at risk EG0020 affected81 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0013 affected68 at risk EG0021 affected81 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0023 affected81 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0022 affected81 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Bone erosion	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Rheumatoid nodule	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Toe deformity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Asthenia	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG00011 affected66 at risk EG00111 affected68 at risk EG0026 affected81 at risk
Pyrexia	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected66 at risk EG0014 affected68 at risk EG0024 affected81 at risk
Fatigue	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0023 affected81 at risk
Oedema peripheral	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Feeling hot	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Chest pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0022 affected81 at risk
Drug intolerance	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Face oedema	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Malaise	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Oedema	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Adverse drug reaction	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Chest discomfort	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Chills	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Cyst	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Gait disturbance	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
General physical health deterioration	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Influenza like illness	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Infusion site phlebitis	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Injection site pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Localised oedema	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Mucosal inflammation	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Sense of oppression	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0007 affected66 at risk EG0015 affected68 at risk EG0026 affected81 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 affected66 at risk EG0011 affected68 at risk EG0024 affected81 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected66 at risk EG0012 affected68 at risk EG0022 affected81 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected66 at risk EG0012 affected68 at risk EG0022 affected81 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0013 affected68 at risk EG0021 affected81 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0022 affected81 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0013 affected68 at risk EG0021 affected81 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Gingivitis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Toothache	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Melaena	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0007 affected66 at risk EG00111 affected68 at risk EG00210 affected81 at risk
Sciatica	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected66 at risk EG0016 affected68 at risk EG0024 affected81 at risk
Migraine	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0013 affected68 at risk EG0021 affected81 at risk
Restless legs syndrome	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Burning sensation	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Cervical root pain	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Dystonia	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Epilepsy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Memory impairment	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Paraesthesia	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Parkinsonism	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Sinus headache	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Syncope	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00011 affected66 at risk EG0014 affected68 at risk EG0023 affected81 at risk
Larynx irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected68 at risk EG0022 affected81 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0016 affected68 at risk EG0025 affected81 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0013 affected68 at risk EG0022 affected81 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0007 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected68 at risk EG0021 affected81 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0023 affected81 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Diabetes mellitus non-insulin-dependent	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Obesity	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected66 at risk EG0011 affected68 at risk EG0023 affected81 at risk
Hot flush	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected66 at risk EG0012 affected68 at risk EG0023 affected81 at risk
Hypertensive crisis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0022 affected81 at risk
Arteriosclerosis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Phlebitis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Vasculitis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Venous insufficiency	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Venous thrombosis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Depression	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0015 affected68 at risk EG0025 affected81 at risk
Insomnia	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0014 affected68 at risk EG0022 affected81 at risk
Anxiety	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0013 affected68 at risk EG0020 affected81 at risk
Sleep disorder	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Depressive symptom	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Mania	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Transaminases increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Weight increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Eosinophil count increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Hepatic enzyme increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Weight decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Alanine aminotransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Bacteria urine identified	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Blood phosphorus decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Blood thyroid stimulating hormone decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Cardiac murmur	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Deoxyribonucleic acid (DNA) antibody positive	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Electrocardiogram repolarisation abnormality	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Lymphocyte count decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Neutrophil count decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Neutrophil count increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
White blood cell count increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Conjunctivitis	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Cataract	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Dry eye	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Chalazion	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Visual acuity reduced	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Visual disturbance	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0022 affected81 at risk
Eye irritation	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Eye pain	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Keratitis	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Keratoconjunctivitis sicca	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Ocular discomfort	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Ocular hyperaemia	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Ocular hypertension	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Retinal detachment	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Retinopathy hypertensive	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Uveitis	Eye disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected68 at risk EG0023 affected81 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 affected66 at risk EG0011 affected68 at risk EG0023 affected81 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Vaginal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Tachycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0013 affected68 at risk EG0021 affected81 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Angina pectoris	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Bundle branch block left	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Palpitations	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Haematuria	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0013 affected68 at risk EG0020 affected81 at risk
Calculus bladder	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Dysuria	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Proteinuria	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Renal colic	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Renal impairment	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Bartholinitis	Reproductive system and breast disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Cystocele	Reproductive system and breast disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Cataract operation	Surgical and medical procedures	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0021 affected81 at risk
Apicectomy	Surgical and medical procedures	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Corneal operation	Surgical and medical procedures	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Therapy regimen changed	Surgical and medical procedures	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0011 affected68 at risk EG0020 affected81 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0012 affected68 at risk EG0020 affected81 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Hypersensitivity	Immune system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0022 affected81 at risk
Allergy to chemicals	Immune system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected66 at risk EG0010 affected68 at risk EG0021 affected81 at risk
Goitre	Endocrine disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected66 at risk EG0010 affected68 at risk EG0020 affected81 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Abbeville		80142	France

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
BG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
BG002	Nonrandomized: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Randomized Retreatment Arm A: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.	19	66	61	66
EG001	Randomized Retreatment Arm B: Rituximab 1000 mg x 2	Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.	25	68	65	68
EG002	Nonrandomized: Rituximab 1000 mg	Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.	16	81	72	81