A Phase 3 interventional study of rituximab [MabThera/Rituxan] in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 51 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-18.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 193 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
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Exclusion Criteria:
Drug: rituximab [MabThera/Rituxan]
1g iv on days 1 and 15
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Rituximab Plus Methotrexate (MTX) |
|---|---|
| Started | 193 |
| Completed | 93 |
| Not completed | 100 |
| Withdrew: Adverse event | 5 |
| Withdrew: Additional or changed therapy | 48 |
| Withdrew: Lack of efficacy | 11 |
| Withdrew: Protocol violation | 4 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Administrative problems | 1 |
| Withdrew: Other | 20 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Change From Baseline in DAS28 Score at Week 24 | -2.12 ± 1.41 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=173) | 5.15 ± 1.09 |
| Course 1: FU Week 8 (n=171) | 4.09 ± 1.22 |
| Course 1: FU Week 16 (n=167) | 3.72 ± 1.29 |
| Course 1: FU Week 24 (n=163) | 3.78 ± 1.25 |
| Course 1: FU Month 9 (n=76) | 3.94 ± 1.56 |
| Course 1: FU Month 12 (n=38) | 3.79 ± 1.38 |
| Course 2: FU Week 8 (n=104) | 3.69 ± 1.25 |
| Course 2: FU Week 16 (n=106) | 3.34 ± 1.04 |
| Course 2: FU Week 24 (n=107) | 3.56 ± 1.26 |
| Course 2: FU Month 9 (n=65) | 3.53 ± 1.34 |
| Course 2: FU Month 12 (n=47) | 3.98 ± 1.50 |
| Course 3: FU Week 8 (n=35) | 3.59 ± 1.09 |
| Course 3: FU Week 16 (n=37) | 3.25 ± 1.07 |
| Course 3: FU Week 24 (n=38) | 3.65 ± 1.39 |
| Course 3: FU Month 9 (n=24) | 3.94 ± 1.33 |
| Course 3: FU Month 12 (n=18) | 4.12 ± 1.22 |
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 | Rituximab Plus MTX |
|---|---|
| Course 1 (n=173) | 78.0 |
| Course 2 (n=107) | 86.9 |
| Course 3 (n=38) | 86.8 |
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.
| percentage of participants | Rituximab Pluse MTX |
|---|---|
| Course 1: Good response (n=173) | 32.4 |
| Course 1: Moderate response (n=173) | 45.7 |
| Course 2: Good response (n=107) | 43.0 |
| Course 2: Moderate response (n=107) | 43.9 |
| Course 3: Good response (n=38) | 44.7 |
| Course 3: Moderate response (n=38) | 42.1 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=173) | 1.43 ± 0.64 |
| Course 1: FU Week 8 (n=171) | 1.36 ± 0.68 |
| Course 1: FU Week 16 (n=164) | 1.31 ± 0.67 |
| Course 1: FU Week 24 (n=164) | 1.28 ± 0.68 |
| Course 1: FU Month 9 (n=76) | 1.33 ± 0.72 |
| Course 1: FU Month 12 (n=39) | 1.29 ± 0.84 |
| Course 2: FU Week 8 (n=100) | 1.31 ± 0.62 |
| Course 2: FU Week 16 (n=104) | 1.26 ± 0.61 |
| Course 2: FU Week 24 (n=106) | 1.22 ± 0.59 |
| Course 2: FU Month 9 (n=65) | 1.34 ± 0.62 |
| Course 2: FU Month 12 (n=49) | 1.38 ± 0.65 |
| Course 3: FU Week 8 (n=34) | 1.25 ± 0.63 |
| Course 3: FU Week 16 (n=37) | 1.25 ± 0.67 |
| Course 3: FU Week 24 (n=38) | 1.25 ± 0.63 |
| Course 3: FU Month 9 (n=25) | 1.12 ± 0.59 |
| Course 3: FU Month 12 (n=17) | 1.35 ± 0.57 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=169) | 20.16 ± 11.37 |
| Course 1: FU Week 8 (n=165) | 18.48 ± 11.39 |
| Course 1: FU Week 16 (n=157) | 18.81 ± 12.14 |
| Course 1: FU Week 24 (n=161) | 17.75 ± 11.76 |
| Course 1: FU Month 9 (n=72) | 18.17 ± 12.53 |
| Course 1: FU Month 12 (n=35) | 20.77 ± 13.48 |
| Course 2: FU Week 8 (n=99) | 16.43 ± 11.18 |
| Course 2: FU Week 16 (n=101) | 16.19 ± 11.22 |
| Course 2: FU Week 24 (n=104) | 15.77 ± 11.17 |
| Course 2: FU Month 9 (n=65) | 15.86 ± 11.67 |
| Course 2: FU Month 12 (n=47) | 16.40 ± 10.68 |
| Course 3: FU Week 8 (n=34) | 15.71 ± 11.44 |
| Course 3: FU Week 16 (n=36) | 16.82 ± 12.53 |
| Course 3: FU Week 24 (n=36) | 14.98 ± 11.21 |
| Course 3: FU Month 9 (n=24) | 17.70 ± 12.49 |
| Course 3: FU Month 12 (n=17) | 21.40 ± 12.74 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=171) | 34.57 ± 7.83 |
| Course 1: FU Week 8 (n=165) | 36.28 ± 8.43 |
| Course 1: FU Week 16 (n=160) | 37.23 ± 8.34 |
| Course 1: FU Week 24 (n=161) | 37.94 ± 8.64 |
| Course 1: FU Month 9 (n=74) | 37.28 ± 9.61 |
| Course 1: FU Month 12 (n=39) | 36.92 ± 9.49 |
| Course 2: FU Week 8 (n=102) | 37.27 ± 8.39 |
| Course 2: FU Week 16 (n=105) | 38.34 ± 8.11 |
| Course 2: FU Week 24 (n=103) | 39.17 ± 8.01 |
| Course 2: FU Month 9 (n=66) | 38.68 ± 7.69 |
| Course 2: FU Month 12 (n=48) | 37.34 ± 8.80 |
| Course 3: FU Week 8 (n=33) | 37.95 ± 8.12 |
| Course 3: FU Week 16 (n=35) | 39.43 ± 8.41 |
| Course 3: FU Week 24 (n=36) | 37.62 ± 8.85 |
| Course 3: FU Month 9 (n=23) | 37.99 ± 6.41 |
| Course 3: FU Month 12 (n=15) | 34.95 ± 6.32 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=171) | 44.04 ± 12.76 |
| Course 1: FU Week 8 (n=165) | 45.32 ± 12.42 |
| Course 1: FU Week 16 (n=160) | 45.06 ± 12.06 |
| Course 1: FU Week 24 (n=161) | 45.18 ± 12.59 |
| Course 1: FU Month 9 (n=74) | 44.35 ± 13.38 |
| Course 1: FU Month 12 (n=39) | 41.95 ± 14.30 |
| Course 2: FU Week 8 (n=102) | 45.94 ± 11.34 |
| Course 2: FU Week 16 (n=105) | 45.99 ± 11.71 |
| Course 2: FU Week 24 (n=103) | 46.29 ± 11.89 |
| Course 2: FU Month 9 (n=66) | 46.93 ± 13.56 |
| Course 2: FU Month 12 (n=48) | 45.90 ± 12.33 |
| Course 3: FU Week 8 (n=33) | 46.22 ± 10.79 |
| Course 3: FU Week 16 (n=35) | 45.52 ± 13.41 |
| Course 3: FU Week 24 (n=36) | 46.38 ± 12.20 |
| Course 3: FU Month 9 (n=23) | 44.41 ± 13.96 |
| Course 3: FU Month 12 (n=15) | 43.67 ± 13.73 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=172) | 43.26 ± 24.74 |
| Course 1: FU Week 8 (n=170) | 46.80 ± 25.20 |
| Course 1: FU Week 16 (n=164) | 46.85 ± 25.16 |
| Course 1: FU Week 24 (n=164) | 49.58 ± 26.45 |
| Course 1: FU Month 9 (n=76) | 47.30 ± 26.17 |
| Course 1: Follow-up Month 12 (n=39) | 46.92 ± 30.21 |
| Course 2: FU Week 8 (n=105) | 47.17 ± 24.51 |
| Course 2: FU Week 16 (n=106) | 49.03 ± 24.91 |
| Course 2: FU Week 24 (n=107) | 51.10 ± 24.23 |
| Course 2: FU Month 9 (n=66) | 50.50 ± 22.87 |
| Course 2: FU Month 12 (n=49) | 47.41 ± 23.62 |
| Course 3: FU Week 8 (n=35) | 48.01 ± 26.63 |
| Course 3: FU Week 16 (n=37) | 51.35 ± 26.84 |
| Course 3: FU Week 24 (n=38) | 46.32 ± 28.44 |
| Course 3: FU Month 9 (n=25) | 48.23 ± 26.16 |
| Course 3: FU Month 12 (n=17) | 48.99 ± 29.37 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=172) | 37.22 ± 18.00 |
| Course 1: FU Week 8 (n=169) | 46.06 ± 20.62 |
| Course 1: FU Week 16 (n=164) | 47.98 ± 22.29 |
| Course 1: FU Week 24 (n=164) | 48.70 ± 21.39 |
| Course 1: FU Month 9 (n=75) | 46.55 ± 25.29 |
| Course 1: FU Month 12 (n=39) | 44.10 ± 25.24 |
| Course 2: FU Week 8 (n=105) | 47.15 ± 20.93 |
| Course 2: FU Week 16 (n=106) | 50.34 ± 21.60 |
| Course 2: FU Week 24 (n=104) | 51.38 ± 22.71 |
| Course 2: FU Month 9 (n=66) | 51.23 ± 20.68 |
| Course 2: FU Month 12 (n=48) | 48.58 ± 24.00 |
| Course 3: FU Week 8 (n=35) | 47.60 ± 18.98 |
| Course 3: FU Week 16 (n=36) | 51.94 ± 18.94 |
| Course 3: FU Week 24 (n=38) | 47.92 ± 21.00 |
| Course 3: FU Month 9 (n=25) | 43.24 ± 19.15 |
| Course 3: FU Month 12 (n=16) | 32.56 ± 18.49 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=173) | 45.85 ± 23.75 |
| Course 1: FU Week 8 (n=170) | 50.04 ± 24.11 |
| Course 1: FU Week 16 (n=166) | 51.28 ± 24.43 |
| Course 1: FU Week 24 (n=165) | 52.92 ± 24.15 |
| Course 1: FU Month 9 (n=76) | 49.51 ± 25.41 |
| Course 1: FU Month 12 (n=39) | 47.44 ± 25.80 |
| Course 2: FU Week 8 (n=103) | 52.79 ± 24.09 |
| Course 2: FU Week 16 (n=106) | 53.54 ± 21.54 |
| Course 2: FU Week 24 (n=107) | 55.32 ± 23.11 |
| Course 2: FU Month 9 (n=66) | 56.91 ± 20.89 |
| Course 2: FU Month 12 (n=49) | 52.98 ± 20.19 |
| Course 3: FU Week 8 (n=35) | 52.32 ± 21.55 |
| Course 3: FU Week 16 (n=36) | 53.47 ± 25.64 |
| Course 3: FU Week 24 (n=38) | 50.99 ± 23.41 |
| Course 3: FU Month 9 (n=24) | 51.82 ± 23.05 |
| Course 3: FU Month 12 (n=17) | 44.49 ± 22.84 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=173) | 57.80 ± 27.52 |
| Course 1: FU Week 8 (n=170) | 61.91 ± 26.27 |
| Course 1: FU Week 16 (n=166) | 60.44 ± 28.06 |
| Course 1: FU Week 24 (n=165) | 62.12 ± 26.87 |
| Course 1: FU Month 9 (n=76) | 56.52 ± 28.52 |
| Course 1: FU Month 12 (n=39) | 55.98 ± 30.82 |
| Course 2: FU Week 8 (n=104) | 61.30 ± 25.41 |
| Course 2: FU Week 16 (n=106) | 62.74 ± 25.28 |
| Course 2: FU Week 24 (n=107) | 61.53 ± 25.41 |
| Course 2: FU Month 9 (n=66) | 62.75 ± 26.28 |
| Course 2: FU Month 12 (n=49) | 61.05 ± 23.22 |
| Course 3: FU Week 8 (n=34) | 60.29 ± 25.55 |
| Course 3: FU Week 16 (n=37) | 61.26 ± 29.35 |
| Course 3: FU Week 24 (n=38) | 60.53 ± 26.04 |
| Course 3: FU Month 9 (n=24) | 54.51 ± 31.37 |
| Course 3: FU Month 12 (n=17) | 55.39 ± 25.84 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=171) | 61.71 ± 21.25 |
| Course 1: FU Week 8 (n=169) | 64.38 ± 20.36 |
| Course 1: FU Week 16 (n=164) | 64.70 ± 20.02 |
| Course 1: FU Week 24 (n=165) | 64.26 ± 20.77 |
| Course 1: FU Month 9 (n=76) | 64.08 ± 23.23 |
| Course 1: FU Month 12 (n=39) | 57.85 ± 24.50 |
| Course 2: FU Week 8 (n=105) | 65.44 ± 19.45 |
| Course 2: FU Week 16 (n=106) | 65.33 ± 19.75 |
| Course 2: FU Week 24 (n=106) | 66.45 ± 19.63 |
| Course 2: FU Month 9 (n=66) | 67.67 ± 20.60 |
| Course 2: FU Month 12 (n=49) | 65.82 ± 19.75 |
| Course 3: FU Week 8 (n=35) | 66.43 ± 18.01 |
| Course 3: FU Week 16 (n=37) | 63.99 ± 24.25 |
| Course 3: FU Week 24 (n=38) | 65.46 ± 20.87 |
| Course 3: FU Month 9 (n=25) | 62.80 ± 20.82 |
| Course 3: FU Month 12 (n=16) | 61.88 ± 21.20 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=173) | 66.47 ± 25.39 |
| Course 1: FU Week 8 (n=171) | 69.01 ± 26.55 |
| Course 1: FU Week 16 (n=166) | 68.75 ± 25.63 |
| Course 1: FU Week 24 (n=165) | 69.62 ± 26.77 |
| Course 1: FU Month 9 (n=75) | 67.50 ± 27.34 |
| Course 1: FU Month 12 (n=39) | 66.67 ± 30.26 |
| Course 2: FU Week 8 (n=104) | 71.27 ± 24.44 |
| Course 2: FU Week 16 (n=106) | 71.70 ± 24.60 |
| Course 2: FU Week 24 (n=107) | 72.31 ± 25.76 |
| Course 2: FU Month 9 (n=66) | 74.62 ± 27.21 |
| Course 2: FU Month 12 (n=49) | 71.68 ± 24.84 |
| Course 3: FU Week 8 (n=35) | 70.00 ± 23.13 |
| Course 3: FU Week 16 (n=37) | 66.22 ± 25.15 |
| Course 3: FU Week 24 (n=38) | 68.09 ± 24.95 |
| Course 3: FU Month 9 (n=25) | 72.50 ± 24.74 |
| Course 3: FU Month 12 (n=17) | 66.18 ± 32.71 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=172) | 46.33 ± 20.61 |
| Course 1: FU Week 8 (n=169) | 49.51 ± 21.04 |
| Course 1: FU Week 16 (n=164) | 50.22 ± 20.86 |
| Course 1: FU Week 24 (n=165) | 50.57 ± 21.99 |
| Course 1: FU Month 9 (n=76) | 50.82 ± 22.53 |
| Course 1: FU Month 12 (n=39) | 45.99 ± 22.77 |
| Course 2: FU Week 8 (n=105) | 50.60 ± 20.59 |
| Course 2: FU Week 16 (n=106) | 52.42 ± 20.94 |
| Course 2: FU Week 24 (n=106) | 54.01 ± 21.81 |
| Course 2: FU Month 9 (n=66) | 55.49 ± 19.19 |
| Course 2: FU Month 12 (n=49) | 52.30 ± 18.47 |
| Course 3: FU Week 8 (n=35) | 53.93 ± 24.12 |
| Course 3: FU Week 16 (n=37) | 51.35 ± 24.57 |
| Course 3: FU Week 24 (n=38) | 52.14 ± 24.33 |
| Course 3: FU Month 9 (n=25) | 52.25 ± 26.01 |
| Course 3: FU Month 12 (n=16) | 42.97 ± 23.92 |
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.
| scores on a scale | Rituximab Plus MTX |
|---|---|
| Screening (n=173) | 45.74 ± 15.72 |
| Course 1: FU Week 8 (n=171) | 47.46 ± 16.56 |
| Course 1: FU Week 16 (n=166) | 50.82 ± 16.23 |
| Course 1: FU Week 24 (n=164) | 50.65 ± 16.91 |
| Course 1: FU Month 9 (n=76) | 49.38 ± 18.15 |
| Course 1: FU Month 12 (n=39) | 46.15 ± 17.85 |
| Course 2: FU Week 8 (n=104) | 50.32 ± 14.43 |
| Course 2: FU Week 16 (n=106) | 52.04 ± 14.78 |
| Course 2: FU Week 24 (n=107) | 52.93 ± 14.92 |
| Course 2: FU Month 9 (n=66) | 51.04 ± 16.95 |
| Course 2: FU Month 12 (n=49) | 48.98 ± 18.60 |
| Course 3: FU Week 8 (n=35) | 52.27 ± 13.09 |
| Course 3: FU Week 16 (n=37) | 52.14 ± 14.07 |
| Course 3: FU Week 24 (n=37) | 52.90 ± 12.31 |
| Course 3: FU Month 9 (n=25) | 50.54 ± 12.96 |
| Course 3: FU Month 12 (n=17) | 45.29 ± 14.37 |
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.
| percentage of participants | Rituximab Plus MTX |
|---|---|
| Course 1: ACR20 (n=173) | 38.7 |
| Course 1: ACR50 (n=173) | 19.1 |
| Course 1: ACR70 (n=173) | 5.2 |
| Course 2: ACR20 (n=107) | 51.4 |
| Course 2: ACR50 (n=107) | 26.2 |
| Course 2: ACR70 (n=107) | 5.6 |
| Course 3: ACR20 (n=38) | 55.3 |
| Course 3: ACR50 (n=38) | 28.9 |
| Course 3: ACR70 (n=38) | 7.9 |
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.
| swollen joints | Rituximab Plus MTX |
|---|---|
| Screening (n=165) | 8.52 ± 5.58 |
| Course 1 FU Week 24 (n=165) | 4.09 ± 5.29 |
| Course 2 FU Week 24 (n=105) | 3.65 ± 4.79 |
| Course 3 FU Week 24 (n=37) | 3.51 ± 5.01 |
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.
| tender joints | Rituximab Plus MTX |
|---|---|
| Screening (n=165) | 12.92 ± 9.12 |
| Course 1 FU Week 24 (n=165) | 7.32 ± 9.60 |
| Course 2 FU Week 24 (n=105) | 6.31 ± 7.88 |
| Course 3 FU Week 24 (n=37) | 7.00 ± 9.02 |
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).
| mm | Rituximab Plus MTX |
|---|---|
| Baseline (n=167) | 64.17 ± 15.12 |
| Course 1 Week 24 (n=167) | 28.50 ± 22.23 |
| Course 2 Week 24 (n=106) | 27.67 ± 24.32 |
| Course 3 Week 24 (n=38) | 28.82 ± 22.52 |
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).
| mm | Rituximab Plus MTX |
|---|---|
| Baseline (n=164) | 63.40 ± 21.10 |
| Course 1 Week 24 (n=164) | 34.13 ± 23.60 |
| Course 2 Week 24 (n=107) | 34.50 ± 23.17 |
| Course 3 Week 24 (n=38) | 33.66 ± 23.77 |
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".
| mm | Rituximab Plus MTX |
|---|---|
| Baseline (n=164) | 61.90 ± 21.26 |
| Course 1 Week 24 (n=164) | 35.02 ± 23.50 |
| Course 2 Week 24 (n=107) | 35.12 ± 23.15 |
| Course 3 Week 24 (n=38) | 34.82 ± 25.63 |
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.
| mg/dL | Rituximab Plus MTX |
|---|---|
| Baseline (n=164) | 1.82 ± 2.41 |
| Course 1 Week 24 (n=164) | 0.89 ± 1.35 |
| Course 2 Week 24 (n=105) | 0.88 ± 1.16 |
| Course 3 Week 24 (n=38) | 0.84 ± 0.96 |
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.
| mm/hr | Rituximab Plus MTX |
|---|---|
| Baseline (n=166) | 31.30 ± 19.66 |
| Course 1 Week 24 (n=166) | 19.87 ± 14.20 |
| Course 2 Week 24 (n=107) | 19.45 ± 16.42 |
| Course 3 Week 24 (n=38) | 18.74 ± 11.59 |
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.
| IU/mL | Rituximab Plus MTX |
|---|---|
| Baseline (n=158) | 187.18 ± 339.42 |
| Course 1 Week 24 (n=158) | 70.16 ± 163.80 |
| Course 2 Week 24 (n=102) | 63.17 ± 144.50 |
| Course 3 Week 24 (n=38) | 58.52 ± 117.73 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rituximab Plus MTX | — | 47/193 (24.4%) | 105/193 (54.4%) |
| Event | Rituximab Plus MTX |
|---|---|
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 5/193 |
| PneumoniaInfections and infestations | 2/193 |
| Respiratory tract infectionInfections and infestations | 2/193 |
| ArthritisMusculoskeletal and connective tissue disorders | 2/193 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 2/193 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/193 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/193 |
| Coronary artery diseaseCardiac disorders | 2/193 |
| BronchitisInfections and infestations | 2/193 |
| GangreneInfections and infestations | 1/193 |
| Event | Rituximab Plus MTX |
|---|---|
| NasopharyngitisInfections and infestations | 43/193 |
| BronchitisInfections and infestations | 17/193 |
| Upper respiratory tract infectionInfections and infestations | 12/193 |
| DiarrhoeaGastrointestinal disorders | 11/193 |
| GastroenteritisInfections and infestations | 8/193 |
| Respiratory tract infectionInfections and infestations | 8/193 |
| CoughRespiratory, thoracic and mediastinal disorders | 8/193 |
| Infusion related reactionGeneral disorders | 7/193 |
| HypertensionVascular disorders | 7/193 |
| NauseaGastrointestinal disorders | 6/193 |
Safety Population: all participants who received at least 1 dose of the trial medication and had at least 1 safety follow-up, whether withdrawn prematurely or not. A safety follow-up was assumed if the participant had at least 1 documented study visit after baseline or if at least 1 adverse event had been documented with start date after baseline.
| Age, Continuous(years) | Rituximab Plus MTX |
|---|---|
| Mean | 55.5 (26 to 78) |
| Sex: Female, Male(Participants) | Rituximab Plus MTX |
|---|---|
| Female | 146 |
| Male | 47 |
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Hoffmann-La Roche