Rheumatoid Arthritis
Conditions
Brief summary
This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 \>2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Interventions
DRUGrituximab [MabThera/Rituxan]
1g iv on days 1 and 15
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit; * eligible for re-treatment (DAS28 \>2.6 after week 24, swollen joint count \>=4, tender joint count \>=4).
Exclusion criteria
* patients who have withdrawn from treatment in ML19070 pre-week 16; * patients with a previous response in DAS28 \<0.6 to MabThera after week 16; * concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in DAS28 Score at Week 24 | Week 24 | DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course | Week 24 | DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \>1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 to ≤5.1 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1. |
| Percentage of Participants Achieving a Response By EULAR Category and Treatment Course | Week 24 | Response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \>1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 to ≤5.1 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline \>0.6 and ≤1.2 with a DAS28 score \> 5.1. |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | HAQ-DI was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered ;total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The questionnaire was provided in a German translation and was scored based on the instructions from the Stanford University Medical Center. |
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | FACIT-F was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The FACIT fatigue scale is based on a 13-item questionnaire to assess the therapy-induced fatigue. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation. |
| Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
| SF-36 MCS by Treatment Course | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
| SF-36 Domain Scores by Treatment Course - Physical Functioning | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
| SF-36 Domain Scores by Treatment Course - Bodily Pain | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
| SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
| SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
| SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
| DAS28 Score by Treatment Course and Follow-up (FU) Visit | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28 consists of SJC and TJC measurements, the ESR (measured in mm/hr), and Patient Global Asessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| SF-36 Domain Scores by Treatment Course - Vitality | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
| SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | 24 weeks after each course | ACR response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). ACR20/50/70 response: ≥20/50/70%, respectively, improvement in SJC or TJC and 20/50/70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participants assessment of functional disability via HAQ-DI, and 5) C-reactive protein (CRP) or ESR at each visit. |
| Swollen Joint Count | Screening and Week 24 | Mean sum of 28 swollen joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. |
| Tender Joint Count | Screening and Week 24 | Mean sum of 28 tender joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. |
| Physician's Global Assessment of Disease Activity | Baseline and Week 24 | Physician's Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Physicians were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity). |
| Patient's Global Assessment of Disease Activity | Baseline and Week 24 | Patient Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity). |
| Patient's Assessment of Pain | Baseline and Week 24 | Patient Assessment of Pain was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as unbearable pain. |
| C-Reactive Protein | Baseline and Week 24 | CRP measured in milligrams per deciliter (mg/dL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. |
| Erythrocyte Sedimentation Rate | Baseline and Week 24 | ESR mean scores measured in mm/hr at was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. |
| Rheumatoid Factor (RF) | Baseline and Week 24 | RF measured in international units per milliliter (IU/mL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. |
| SF-36 Domain Scores by Treatment Course - Social Functioning | Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12 | SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Plus MTX Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 \>0.6 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment. | 193 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Additional or changed therapy | 48 |
| Overall Study | Administrative problems | 1 |
| Overall Study | Adverse Event | 5 |
| Overall Study | Lack of Efficacy | 11 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Other | 20 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Rituximab Plus MTX |
|---|---|
| Age, Continuous | 55.5 years |
| Sex: Female, Male Female | 146 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 105 / 193 |
| serious Total, serious adverse events | 47 / 193 |
Outcome results
Primary
Change From Baseline in DAS28 Score at Week 24
DAS28 calculated from the swollen joint count (SJC) and tender joint count (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and Patient Global Asessment of disease activity (participant- rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). A clinically meaningful improvement in DAS28 was defined as an improvement of 1.2 units.
Time frame: Week 24
Population: Intent-to-Treat (ITT) Population: all participants who signed the informed consent form, received at least 1 dose of study medication, and where the DAS28 was measured at least once under study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab Plus MTX | Change From Baseline in DAS28 Score at Week 24 | -2.12 scores on a scale | Standard Deviation 1.41 |
Secondary
C-Reactive Protein
CRP measured in milligrams per deciliter (mg/dL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.
Time frame: Baseline and Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | C-Reactive Protein | Course 3 Week 24 (n=38) | 0.84 mg/dL | Standard Deviation 0.96 |
| Rituximab Plus MTX | C-Reactive Protein | Baseline (n=164) | 1.82 mg/dL | Standard Deviation 2.41 |
| Rituximab Plus MTX | C-Reactive Protein | Course 1 Week 24 (n=164) | 0.89 mg/dL | Standard Deviation 1.35 |
| Rituximab Plus MTX | C-Reactive Protein | Course 2 Week 24 (n=105) | 0.88 mg/dL | Standard Deviation 1.16 |
Secondary
DAS28 Score by Treatment Course and Follow-up (FU) Visit
DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28 consists of SJC and TJC measurements, the ESR (measured in mm/hr), and Patient Global Asessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n (number) = number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Screening (n=173) | 5.15 scores on a scale | Standard Deviation 1.09 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 1: FU Week 8 (n=171) | 4.09 scores on a scale | Standard Deviation 1.22 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 1: FU Week 16 (n=167) | 3.72 scores on a scale | Standard Deviation 1.29 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 1: FU Week 24 (n=163) | 3.78 scores on a scale | Standard Deviation 1.25 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 1: FU Month 9 (n=76) | 3.94 scores on a scale | Standard Deviation 1.56 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 1: FU Month 12 (n=38) | 3.79 scores on a scale | Standard Deviation 1.38 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 2: FU Week 8 (n=104) | 3.69 scores on a scale | Standard Deviation 1.25 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 2: FU Week 16 (n=106) | 3.34 scores on a scale | Standard Deviation 1.04 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 2: FU Week 24 (n=107) | 3.56 scores on a scale | Standard Deviation 1.26 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 2: FU Month 9 (n=65) | 3.53 scores on a scale | Standard Deviation 1.34 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 2: FU Month 12 (n=47) | 3.98 scores on a scale | Standard Deviation 1.5 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 3: FU Week 8 (n=35) | 3.59 scores on a scale | Standard Deviation 1.09 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 3: FU Week 16 (n=37) | 3.25 scores on a scale | Standard Deviation 1.07 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 3: FU Week 24 (n=38) | 3.65 scores on a scale | Standard Deviation 1.39 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 3: FU Month 9 (n=24) | 3.94 scores on a scale | Standard Deviation 1.33 |
| Rituximab Plus MTX | DAS28 Score by Treatment Course and Follow-up (FU) Visit | Course 3: FU Month 12 (n=18) | 4.12 scores on a scale | Standard Deviation 1.22 |
Secondary
Erythrocyte Sedimentation Rate
ESR mean scores measured in mm/hr at was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.
Time frame: Baseline and Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Erythrocyte Sedimentation Rate | Baseline (n=166) | 31.30 mm/hr | Standard Deviation 19.66 |
| Rituximab Plus MTX | Erythrocyte Sedimentation Rate | Course 1 Week 24 (n=166) | 19.87 mm/hr | Standard Deviation 14.2 |
| Rituximab Plus MTX | Erythrocyte Sedimentation Rate | Course 2 Week 24 (n=107) | 19.45 mm/hr | Standard Deviation 16.42 |
| Rituximab Plus MTX | Erythrocyte Sedimentation Rate | Course 3 Week 24 (n=38) | 18.74 mm/hr | Standard Deviation 11.59 |
Secondary
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course
FACIT-F was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The FACIT fatigue scale is based on a 13-item questionnaire to assess the therapy-induced fatigue. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Screening (n=169) | 20.16 scores on a scale | Standard Deviation 11.37 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 1: FU Week 8 (n=165) | 18.48 scores on a scale | Standard Deviation 11.39 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 1: FU Week 16 (n=157) | 18.81 scores on a scale | Standard Deviation 12.14 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 1: FU Week 24 (n=161) | 17.75 scores on a scale | Standard Deviation 11.76 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 1: FU Month 9 (n=72) | 18.17 scores on a scale | Standard Deviation 12.53 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 1: FU Month 12 (n=35) | 20.77 scores on a scale | Standard Deviation 13.48 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 2: FU Week 8 (n=99) | 16.43 scores on a scale | Standard Deviation 11.18 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 2: FU Week 16 (n=101) | 16.19 scores on a scale | Standard Deviation 11.22 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 2: FU Week 24 (n=104) | 15.77 scores on a scale | Standard Deviation 11.17 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 2: FU Month 9 (n=65) | 15.86 scores on a scale | Standard Deviation 11.67 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 2: FU Month 12 (n=47) | 16.40 scores on a scale | Standard Deviation 10.68 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 3: FU Week 8 (n=34) | 15.71 scores on a scale | Standard Deviation 11.44 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 3: FU Week 16 (n=36) | 16.82 scores on a scale | Standard Deviation 12.53 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 3: FU Week 24 (n=36) | 14.98 scores on a scale | Standard Deviation 11.21 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 3: FU Month 9 (n=24) | 17.70 scores on a scale | Standard Deviation 12.49 |
| Rituximab Plus MTX | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course | Course 3: FU Month 12 (n=17) | 21.40 scores on a scale | Standard Deviation 12.74 |
Secondary
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course
HAQ-DI was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered ;total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The questionnaire was provided in a German translation and was scored based on the instructions from the Stanford University Medical Center.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Screening (n=173) | 1.43 scores on a scale | Standard Deviation 0.64 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 1: FU Week 8 (n=171) | 1.36 scores on a scale | Standard Deviation 0.68 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 1: FU Week 16 (n=164) | 1.31 scores on a scale | Standard Deviation 0.67 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 1: FU Week 24 (n=164) | 1.28 scores on a scale | Standard Deviation 0.68 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 1: FU Month 9 (n=76) | 1.33 scores on a scale | Standard Deviation 0.72 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 1: FU Month 12 (n=39) | 1.29 scores on a scale | Standard Deviation 0.84 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 2: FU Week 8 (n=100) | 1.31 scores on a scale | Standard Deviation 0.62 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 2: FU Week 16 (n=104) | 1.26 scores on a scale | Standard Deviation 0.61 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 2: FU Week 24 (n=106) | 1.22 scores on a scale | Standard Deviation 0.59 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 2: FU Month 9 (n=65) | 1.34 scores on a scale | Standard Deviation 0.62 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 2: FU Month 12 (n=49) | 1.38 scores on a scale | Standard Deviation 0.65 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 3: FU Week 8 (n=34) | 1.25 scores on a scale | Standard Deviation 0.63 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 3: FU Week 16 (n=37) | 1.25 scores on a scale | Standard Deviation 0.67 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 3: FU Week 24 (n=38) | 1.25 scores on a scale | Standard Deviation 0.63 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 3: FU Month 9 (n=25) | 1.12 scores on a scale | Standard Deviation 0.59 |
| Rituximab Plus MTX | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course | Course 3: FU Month 12 (n=17) | 1.35 scores on a scale | Standard Deviation 0.57 |
Secondary
Patient's Assessment of Pain
Patient Assessment of Pain was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as unbearable pain.
Time frame: Baseline and Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Patient's Assessment of Pain | Baseline (n=164) | 61.90 mm | Standard Deviation 21.26 |
| Rituximab Plus MTX | Patient's Assessment of Pain | Course 1 Week 24 (n=164) | 35.02 mm | Standard Deviation 23.5 |
| Rituximab Plus MTX | Patient's Assessment of Pain | Course 2 Week 24 (n=107) | 35.12 mm | Standard Deviation 23.15 |
| Rituximab Plus MTX | Patient's Assessment of Pain | Course 3 Week 24 (n=38) | 34.82 mm | Standard Deviation 25.63 |
Secondary
Patient's Global Assessment of Disease Activity
Patient Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Participants were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity).
Time frame: Baseline and Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Patient's Global Assessment of Disease Activity | Baseline (n=164) | 63.40 mm | Standard Deviation 21.1 |
| Rituximab Plus MTX | Patient's Global Assessment of Disease Activity | Course 1 Week 24 (n=164) | 34.13 mm | Standard Deviation 23.6 |
| Rituximab Plus MTX | Patient's Global Assessment of Disease Activity | Course 2 Week 24 (n=107) | 34.50 mm | Standard Deviation 23.17 |
| Rituximab Plus MTX | Patient's Global Assessment of Disease Activity | Course 3 Week 24 (n=38) | 33.66 mm | Standard Deviation 23.77 |
Secondary
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course
ACR response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). ACR20/50/70 response: ≥20/50/70%, respectively, improvement in SJC or TJC and 20/50/70% improvement in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participants assessment of functional disability via HAQ-DI, and 5) C-reactive protein (CRP) or ESR at each visit.
Time frame: 24 weeks after each course
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Plus MTX | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | Course 1: ACR20 (n=173) | 38.7 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | Course 1: ACR50 (n=173) | 19.1 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | Course 1: ACR70 (n=173) | 5.2 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | Course 2: ACR20 (n=107) | 51.4 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | Course 2: ACR50 (n=107) | 26.2 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | Course 2: ACR70 (n=107) | 5.6 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | Course 3: ACR20 (n=38) | 55.3 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | Course 3: ACR50 (n=38) | 28.9 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course | Course 3: ACR70 (n=38) | 7.9 percentage of participants |
Secondary
Percentage of Participants Achieving a Response By EULAR Category and Treatment Course
Response was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \>1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 to ≤5.1 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline \>0.6 and ≤1.2 with a DAS28 score \> 5.1.
Time frame: Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Plus MTX | Percentage of Participants Achieving a Response By EULAR Category and Treatment Course | Course 1: Good response (n=173) | 32.4 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving a Response By EULAR Category and Treatment Course | Course 1: Moderate response (n=173) | 45.7 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving a Response By EULAR Category and Treatment Course | Course 2: Good response (n=107) | 43.0 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving a Response By EULAR Category and Treatment Course | Course 2: Moderate response (n=107) | 43.9 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving a Response By EULAR Category and Treatment Course | Course 3: Good response (n=38) | 44.7 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants Achieving a Response By EULAR Category and Treatment Course | Course 3: Moderate response (n=38) | 42.1 percentage of participants |
Secondary
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course
DAS28 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \>1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 to ≤5.1 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1.
Time frame: Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab Plus MTX | Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course | Course 1 (n=173) | 78.0 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course | Course 2 (n=107) | 86.9 percentage of participants |
| Rituximab Plus MTX | Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course | Course 3 (n=38) | 86.8 percentage of participants |
Secondary
Physician's Global Assessment of Disease Activity
Physician's Global Assessment of Disease Activity was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070. Physicians were to assess the disease activity on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity).
Time frame: Baseline and Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Physician's Global Assessment of Disease Activity | Baseline (n=167) | 64.17 mm | Standard Deviation 15.12 |
| Rituximab Plus MTX | Physician's Global Assessment of Disease Activity | Course 1 Week 24 (n=167) | 28.50 mm | Standard Deviation 22.23 |
| Rituximab Plus MTX | Physician's Global Assessment of Disease Activity | Course 2 Week 24 (n=106) | 27.67 mm | Standard Deviation 24.32 |
| Rituximab Plus MTX | Physician's Global Assessment of Disease Activity | Course 3 Week 24 (n=38) | 28.82 mm | Standard Deviation 22.52 |
Secondary
Rheumatoid Factor (RF)
RF measured in international units per milliliter (IU/mL) was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). Baseline was defined as the original baseline score from assessment performed in Study ML19070.
Time frame: Baseline and Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Rheumatoid Factor (RF) | Baseline (n=158) | 187.18 IU/mL | Standard Deviation 339.42 |
| Rituximab Plus MTX | Rheumatoid Factor (RF) | Course 1 Week 24 (n=158) | 70.16 IU/mL | Standard Deviation 163.8 |
| Rituximab Plus MTX | Rheumatoid Factor (RF) | Course 2 Week 24 (n=102) | 63.17 IU/mL | Standard Deviation 144.5 |
| Rituximab Plus MTX | Rheumatoid Factor (RF) | Course 3 Week 24 (n=38) | 58.52 IU/mL | Standard Deviation 117.73 |
Secondary
SF-36 Domain Scores by Treatment Course - Bodily Pain
SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 3: FU Week 24 (n=38) | 47.92 scores on a scale | Standard Deviation 21 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 3: FU Month 9 (n=25) | 43.24 scores on a scale | Standard Deviation 19.15 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 3: FU Month 12 (n=16) | 32.56 scores on a scale | Standard Deviation 18.49 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Screening (n=172) | 37.22 scores on a scale | Standard Deviation 18 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 1: FU Week 8 (n=169) | 46.06 scores on a scale | Standard Deviation 20.62 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 1: FU Week 16 (n=164) | 47.98 scores on a scale | Standard Deviation 22.29 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 1: FU Week 24 (n=164) | 48.70 scores on a scale | Standard Deviation 21.39 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 1: FU Month 9 (n=75) | 46.55 scores on a scale | Standard Deviation 25.29 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 1: FU Month 12 (n=39) | 44.10 scores on a scale | Standard Deviation 25.24 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 2: FU Week 8 (n=105) | 47.15 scores on a scale | Standard Deviation 20.93 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 2: FU Week 16 (n=106) | 50.34 scores on a scale | Standard Deviation 21.6 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 2: FU Week 24 (n=104) | 51.38 scores on a scale | Standard Deviation 22.71 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 2: FU Month 9 (n=66) | 51.23 scores on a scale | Standard Deviation 20.68 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 2: FU Month 12 (n=48) | 48.58 scores on a scale | Standard Deviation 24 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 3: FU Week 8 (n=35) | 47.60 scores on a scale | Standard Deviation 18.98 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Bodily Pain | Course 3: FU Week 16 (n=36) | 51.94 scores on a scale | Standard Deviation 18.94 |
Secondary
SF-36 Domain Scores by Treatment Course - Emotional Role Functioning
SF-36was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Screening (n=173) | 57.80 scores on a scale | Standard Deviation 27.52 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 1: FU Week 8 (n=170) | 61.91 scores on a scale | Standard Deviation 26.27 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 1: FU Week 16 (n=166) | 60.44 scores on a scale | Standard Deviation 28.06 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 1: FU Week 24 (n=165) | 62.12 scores on a scale | Standard Deviation 26.87 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 1: FU Month 9 (n=76) | 56.52 scores on a scale | Standard Deviation 28.52 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 1: FU Month 12 (n=39) | 55.98 scores on a scale | Standard Deviation 30.82 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 2: FU Week 8 (n=104) | 61.30 scores on a scale | Standard Deviation 25.41 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 2: FU Week 16 (n=106) | 62.74 scores on a scale | Standard Deviation 25.28 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 2: FU Week 24 (n=107) | 61.53 scores on a scale | Standard Deviation 25.41 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 2: FU Month 9 (n=66) | 62.75 scores on a scale | Standard Deviation 26.28 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 2: FU Month 12 (n=49) | 61.05 scores on a scale | Standard Deviation 23.22 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 3: FU Week 8 (n=34) | 60.29 scores on a scale | Standard Deviation 25.55 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 3: FU Week 16 (n=37) | 61.26 scores on a scale | Standard Deviation 29.35 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 3: FU Week 24 (n=38) | 60.53 scores on a scale | Standard Deviation 26.04 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 3: FU Month 9 (n=24) | 54.51 scores on a scale | Standard Deviation 31.37 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Role Functioning | Course 3: FU Month 12 (n=17) | 55.39 scores on a scale | Standard Deviation 25.84 |
Secondary
SF-36 Domain Scores by Treatment Course - Emotional Well-Being
SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Screening (n=171) | 61.71 scores on a scale | Standard Deviation 21.25 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 1: FU Week 8 (n=169) | 64.38 scores on a scale | Standard Deviation 20.36 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 1: FU Week 16 (n=164) | 64.70 scores on a scale | Standard Deviation 20.02 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 1: FU Week 24 (n=165) | 64.26 scores on a scale | Standard Deviation 20.77 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 1: FU Month 9 (n=76) | 64.08 scores on a scale | Standard Deviation 23.23 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 1: FU Month 12 (n=39) | 57.85 scores on a scale | Standard Deviation 24.5 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 2: FU Week 8 (n=105) | 65.44 scores on a scale | Standard Deviation 19.45 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 2: FU Week 16 (n=106) | 65.33 scores on a scale | Standard Deviation 19.75 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 2: FU Week 24 (n=106) | 66.45 scores on a scale | Standard Deviation 19.63 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 2: FU Month 9 (n=66) | 67.67 scores on a scale | Standard Deviation 20.6 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 2: FU Month 12 (n=49) | 65.82 scores on a scale | Standard Deviation 19.75 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 3: FU Week 8 (n=35) | 66.43 scores on a scale | Standard Deviation 18.01 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 3: FU Week 16 (n=37) | 63.99 scores on a scale | Standard Deviation 24.25 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 3: FU Week 24 (n=38) | 65.46 scores on a scale | Standard Deviation 20.87 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 3: FU Month 9 (n=25) | 62.80 scores on a scale | Standard Deviation 20.82 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Emotional Well-Being | Course 3: FU Month 12 (n=16) | 61.88 scores on a scale | Standard Deviation 21.2 |
Secondary
SF-36 Domain Scores by Treatment Course - General Heath Perceptions
SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Screening (n=173) | 45.74 scores on a scale | Standard Deviation 15.72 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 1: FU Week 8 (n=171) | 47.46 scores on a scale | Standard Deviation 16.56 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 1: FU Week 16 (n=166) | 50.82 scores on a scale | Standard Deviation 16.23 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 1: FU Week 24 (n=164) | 50.65 scores on a scale | Standard Deviation 16.91 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 1: FU Month 9 (n=76) | 49.38 scores on a scale | Standard Deviation 18.15 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 1: FU Month 12 (n=39) | 46.15 scores on a scale | Standard Deviation 17.85 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 2: FU Week 8 (n=104) | 50.32 scores on a scale | Standard Deviation 14.43 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 2: FU Week 16 (n=106) | 52.04 scores on a scale | Standard Deviation 14.78 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 2: FU Week 24 (n=107) | 52.93 scores on a scale | Standard Deviation 14.92 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 2: FU Month 9 (n=66) | 51.04 scores on a scale | Standard Deviation 16.95 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 2: FU Month 12 (n=49) | 48.98 scores on a scale | Standard Deviation 18.6 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 3: FU Week 8 (n=35) | 52.27 scores on a scale | Standard Deviation 13.09 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 3: FU Week 16 (n=37) | 52.14 scores on a scale | Standard Deviation 14.07 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 3: FU Week 24 (n=37) | 52.90 scores on a scale | Standard Deviation 12.31 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 3: FU Month 9 (n=25) | 50.54 scores on a scale | Standard Deviation 12.96 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - General Heath Perceptions | Course 3: FU Month 12 (n=17) | 45.29 scores on a scale | Standard Deviation 14.37 |
Secondary
SF-36 Domain Scores by Treatment Course - Physical Functioning
SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Screening (n=172) | 43.26 scores on a scale | Standard Deviation 24.74 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 1: FU Week 8 (n=170) | 46.80 scores on a scale | Standard Deviation 25.2 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 1: FU Week 16 (n=164) | 46.85 scores on a scale | Standard Deviation 25.16 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 1: FU Week 24 (n=164) | 49.58 scores on a scale | Standard Deviation 26.45 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 1: FU Month 9 (n=76) | 47.30 scores on a scale | Standard Deviation 26.17 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 1: Follow-up Month 12 (n=39) | 46.92 scores on a scale | Standard Deviation 30.21 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 2: FU Week 8 (n=105) | 47.17 scores on a scale | Standard Deviation 24.51 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 2: FU Week 16 (n=106) | 49.03 scores on a scale | Standard Deviation 24.91 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 2: FU Week 24 (n=107) | 51.10 scores on a scale | Standard Deviation 24.23 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 2: FU Month 9 (n=66) | 50.50 scores on a scale | Standard Deviation 22.87 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 2: FU Month 12 (n=49) | 47.41 scores on a scale | Standard Deviation 23.62 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 3: FU Week 8 (n=35) | 48.01 scores on a scale | Standard Deviation 26.63 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 3: FU Week 16 (n=37) | 51.35 scores on a scale | Standard Deviation 26.84 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 3: FU Week 24 (n=38) | 46.32 scores on a scale | Standard Deviation 28.44 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 3: FU Month 9 (n=25) | 48.23 scores on a scale | Standard Deviation 26.16 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Functioning | Course 3: FU Month 12 (n=17) | 48.99 scores on a scale | Standard Deviation 29.37 |
Secondary
SF-36 Domain Scores by Treatment Course - Physical Role Functioning
SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Screening (n=173) | 45.85 scores on a scale | Standard Deviation 23.75 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 1: FU Week 8 (n=170) | 50.04 scores on a scale | Standard Deviation 24.11 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 1: FU Week 16 (n=166) | 51.28 scores on a scale | Standard Deviation 24.43 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 1: FU Week 24 (n=165) | 52.92 scores on a scale | Standard Deviation 24.15 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 1: FU Month 9 (n=76) | 49.51 scores on a scale | Standard Deviation 25.41 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 1: FU Month 12 (n=39) | 47.44 scores on a scale | Standard Deviation 25.8 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 2: FU Week 8 (n=103) | 52.79 scores on a scale | Standard Deviation 24.09 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 2: FU Week 16 (n=106) | 53.54 scores on a scale | Standard Deviation 21.54 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 2: FU Week 24 (n=107) | 55.32 scores on a scale | Standard Deviation 23.11 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 2: FU Month 9 (n=66) | 56.91 scores on a scale | Standard Deviation 20.89 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 2: FU Month 12 (n=49) | 52.98 scores on a scale | Standard Deviation 20.19 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 3: FU Week 8 (n=35) | 52.32 scores on a scale | Standard Deviation 21.55 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 3: FU Week 16 (n=36) | 53.47 scores on a scale | Standard Deviation 25.64 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 3: FU Week 24 (n=38) | 50.99 scores on a scale | Standard Deviation 23.41 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 3: FU Month 9 (n=24) | 51.82 scores on a scale | Standard Deviation 23.05 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Physical Role Functioning | Course 3: FU Month 12 (n=17) | 44.49 scores on a scale | Standard Deviation 22.84 |
Secondary
SF-36 Domain Scores by Treatment Course - Social Functioning
SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 1: FU Week 8 (n=171) | 69.01 scores on a scale | Standard Deviation 26.55 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Screening (n=173) | 66.47 scores on a scale | Standard Deviation 25.39 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 1: FU Week 16 (n=166) | 68.75 scores on a scale | Standard Deviation 25.63 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 1: FU Week 24 (n=165) | 69.62 scores on a scale | Standard Deviation 26.77 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 1: FU Month 9 (n=75) | 67.50 scores on a scale | Standard Deviation 27.34 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 1: FU Month 12 (n=39) | 66.67 scores on a scale | Standard Deviation 30.26 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 2: FU Week 8 (n=104) | 71.27 scores on a scale | Standard Deviation 24.44 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 2: FU Week 16 (n=106) | 71.70 scores on a scale | Standard Deviation 24.6 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 2: FU Week 24 (n=107) | 72.31 scores on a scale | Standard Deviation 25.76 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 2: FU Month 9 (n=66) | 74.62 scores on a scale | Standard Deviation 27.21 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 2: FU Month 12 (n=49) | 71.68 scores on a scale | Standard Deviation 24.84 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 3: FU Week 8 (n=35) | 70.00 scores on a scale | Standard Deviation 23.13 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 3: FU Week 16 (n=37) | 66.22 scores on a scale | Standard Deviation 25.15 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 3: FU Week 24 (n=38) | 68.09 scores on a scale | Standard Deviation 24.95 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 3: FU Month 9 (n=25) | 72.50 scores on a scale | Standard Deviation 24.74 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Social Functioning | Course 3: FU Month 12 (n=17) | 66.18 scores on a scale | Standard Deviation 32.71 |
Secondary
SF-36 Domain Scores by Treatment Course - Vitality
SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Screening (n=172) | 46.33 scores on a scale | Standard Deviation 20.61 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 1: FU Week 8 (n=169) | 49.51 scores on a scale | Standard Deviation 21.04 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 1: FU Week 16 (n=164) | 50.22 scores on a scale | Standard Deviation 20.86 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 1: FU Week 24 (n=165) | 50.57 scores on a scale | Standard Deviation 21.99 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 1: FU Month 9 (n=76) | 50.82 scores on a scale | Standard Deviation 22.53 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 1: FU Month 12 (n=39) | 45.99 scores on a scale | Standard Deviation 22.77 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 2: FU Week 8 (n=105) | 50.60 scores on a scale | Standard Deviation 20.59 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 2: FU Week 16 (n=106) | 52.42 scores on a scale | Standard Deviation 20.94 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 2: FU Week 24 (n=106) | 54.01 scores on a scale | Standard Deviation 21.81 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 2: FU Month 9 (n=66) | 55.49 scores on a scale | Standard Deviation 19.19 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 2: FU Month 12 (n=49) | 52.30 scores on a scale | Standard Deviation 18.47 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 3: FU Week 8 (n=35) | 53.93 scores on a scale | Standard Deviation 24.12 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 3: FU Week 16 (n=37) | 51.35 scores on a scale | Standard Deviation 24.57 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 3: FU Week 24 (n=38) | 52.14 scores on a scale | Standard Deviation 24.33 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 3: FU Month 9 (n=25) | 52.25 scores on a scale | Standard Deviation 26.01 |
| Rituximab Plus MTX | SF-36 Domain Scores by Treatment Course - Vitality | Course 3: FU Month 12 (n=16) | 42.97 scores on a scale | Standard Deviation 23.92 |
Secondary
SF-36 MCS by Treatment Course
SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and MCS. The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Screening (n=171) | 44.04 scores on a scale | Standard Deviation 12.76 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 1: FU Week 8 (n=165) | 45.32 scores on a scale | Standard Deviation 12.42 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 1: FU Week 16 (n=160) | 45.06 scores on a scale | Standard Deviation 12.06 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 1: FU Week 24 (n=161) | 45.18 scores on a scale | Standard Deviation 12.59 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 1: FU Month 9 (n=74) | 44.35 scores on a scale | Standard Deviation 13.38 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 1: FU Month 12 (n=39) | 41.95 scores on a scale | Standard Deviation 14.3 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 2: FU Week 8 (n=102) | 45.94 scores on a scale | Standard Deviation 11.34 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 2: FU Week 16 (n=105) | 45.99 scores on a scale | Standard Deviation 11.71 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 2: FU Week 24 (n=103) | 46.29 scores on a scale | Standard Deviation 11.89 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 2: FU Month 9 (n=66) | 46.93 scores on a scale | Standard Deviation 13.56 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 2: FU Month 12 (n=48) | 45.90 scores on a scale | Standard Deviation 12.33 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 3: FU Week 8 (n=33) | 46.22 scores on a scale | Standard Deviation 10.79 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 3: FU Week 16 (n=35) | 45.52 scores on a scale | Standard Deviation 13.41 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 3: FU Week 24 (n=36) | 46.38 scores on a scale | Standard Deviation 12.2 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 3: FU Month 9 (n=23) | 44.41 scores on a scale | Standard Deviation 13.96 |
| Rituximab Plus MTX | SF-36 MCS by Treatment Course | Course 3: FU Month 12 (n=15) | 43.67 scores on a scale | Standard Deviation 13.73 |
Secondary
Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course
SF-36 was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Time frame: Screening, FU Weeks 8, 16, and 24, and FU Months 9 and 12
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Screening (n=171) | 34.57 scores on a scale | Standard Deviation 7.83 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 1: FU Week 8 (n=165) | 36.28 scores on a scale | Standard Deviation 8.43 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 1: FU Week 16 (n=160) | 37.23 scores on a scale | Standard Deviation 8.34 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 1: FU Week 24 (n=161) | 37.94 scores on a scale | Standard Deviation 8.64 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 1: FU Month 9 (n=74) | 37.28 scores on a scale | Standard Deviation 9.61 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 1: FU Month 12 (n=39) | 36.92 scores on a scale | Standard Deviation 9.49 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 2: FU Week 8 (n=102) | 37.27 scores on a scale | Standard Deviation 8.39 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 2: FU Week 16 (n=105) | 38.34 scores on a scale | Standard Deviation 8.11 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 2: FU Week 24 (n=103) | 39.17 scores on a scale | Standard Deviation 8.01 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 2: FU Month 9 (n=66) | 38.68 scores on a scale | Standard Deviation 7.69 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 2: FU Month 12 (n=48) | 37.34 scores on a scale | Standard Deviation 8.8 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 3: FU Week 8 (n=33) | 37.95 scores on a scale | Standard Deviation 8.12 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 3: FU Week 16 (n=35) | 39.43 scores on a scale | Standard Deviation 8.41 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 3: FU Week 24 (n=36) | 37.62 scores on a scale | Standard Deviation 8.85 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 3: FU Month 9 (n=23) | 37.99 scores on a scale | Standard Deviation 6.41 |
| Rituximab Plus MTX | Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course | Course 3: FU Month 12 (n=15) | 34.95 scores on a scale | Standard Deviation 6.32 |
Secondary
Swollen Joint Count
Mean sum of 28 swollen joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Time frame: Screening and Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Swollen Joint Count | Screening (n=165) | 8.52 swollen joints | Standard Deviation 5.58 |
| Rituximab Plus MTX | Swollen Joint Count | Course 1 FU Week 24 (n=165) | 4.09 swollen joints | Standard Deviation 5.29 |
| Rituximab Plus MTX | Swollen Joint Count | Course 2 FU Week 24 (n=105) | 3.65 swollen joints | Standard Deviation 4.79 |
| Rituximab Plus MTX | Swollen Joint Count | Course 3 FU Week 24 (n=37) | 3.51 swollen joints | Standard Deviation 5.01 |
Secondary
Tender Joint Count
Mean sum of 28 tender joints was assessed during follow-up at the specified timepoints following each course of treatment (participants could have received up to 3 courses of treatment with rituximab). The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Time frame: Screening and Week 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab Plus MTX | Tender Joint Count | Screening (n=165) | 12.92 tender joints | Standard Deviation 9.12 |
| Rituximab Plus MTX | Tender Joint Count | Course 1 FU Week 24 (n=165) | 7.32 tender joints | Standard Deviation 9.6 |
| Rituximab Plus MTX | Tender Joint Count | Course 2 FU Week 24 (n=105) | 6.31 tender joints | Standard Deviation 7.88 |
| Rituximab Plus MTX | Tender Joint Count | Course 3 FU Week 24 (n=37) | 7.00 tender joints | Standard Deviation 9.02 |