A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
CompletedPhase 3Results postedLast updated 18 August 2017
What this trial tests
Phase 3 trial testing rituximab [MabThera/Rituxan] in Rheumatoid Arthritis in 193 participants. Completed in 20 September 2011.
Adults 18 to 75, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in DAS28 Score at Week 24Primary· 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.
Group
Value
95% CI
Rituximab Plus MTX
-2.12
± 1.41
DAS28 Score by Treatment Course and Follow-up (FU) VisitSecondary· 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.
Screening (n=173)
Group
Value
95% CI
Rituximab Plus MTX
5.15
± 1.09
Course 1: FU Week 8 (n=171)
Group
Value
95% CI
Rituximab Plus MTX
4.09
± 1.22
Course 1: FU Week 16 (n=167)
Group
Value
95% CI
Rituximab Plus MTX
3.72
± 1.29
Course 1: FU Week 24 (n=163)
Group
Value
95% CI
Rituximab Plus MTX
3.78
± 1.25
Course 1: FU Month 9 (n=76)
Group
Value
95% CI
Rituximab Plus MTX
3.94
± 1.56
Course 1: FU Month 12 (n=38)
Group
Value
95% CI
Rituximab Plus MTX
3.79
± 1.38
Course 2: FU Week 8 (n=104)
Group
Value
95% CI
Rituximab Plus MTX
3.69
± 1.25
Course 2: FU Week 16 (n=106)
Group
Value
95% CI
Rituximab Plus MTX
3.34
± 1.04
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment CourseSecondary· 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 ≤
Course 1 (n=173)
Group
Value
95% CI
Rituximab Plus MTX
78.0
Course 2 (n=107)
Group
Value
95% CI
Rituximab Plus MTX
86.9
Course 3 (n=38)
Group
Value
95% CI
Rituximab Plus MTX
86.8
Percentage of Participants Achieving a Response By EULAR Category and Treatment CourseSecondary· 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 scor
Course 1: Good response (n=173)
Group
Value
95% CI
Rituximab Pluse MTX
32.4
Course 1: Moderate response (n=173)
Group
Value
95% CI
Rituximab Pluse MTX
45.7
Course 2: Good response (n=107)
Group
Value
95% CI
Rituximab Pluse MTX
43.0
Course 2: Moderate response (n=107)
Group
Value
95% CI
Rituximab Pluse MTX
43.9
Course 3: Good response (n=38)
Group
Value
95% CI
Rituximab Pluse MTX
44.7
Course 3: Moderate response (n=38)
Group
Value
95% CI
Rituximab Pluse MTX
42.1
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment CourseSecondary· 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 st
Screening (n=173)
Group
Value
95% CI
Rituximab Plus MTX
1.43
± 0.64
Course 1: FU Week 8 (n=171)
Group
Value
95% CI
Rituximab Plus MTX
1.36
± 0.68
Course 1: FU Week 16 (n=164)
Group
Value
95% CI
Rituximab Plus MTX
1.31
± 0.67
Course 1: FU Week 24 (n=164)
Group
Value
95% CI
Rituximab Plus MTX
1.28
± 0.68
Course 1: FU Month 9 (n=76)
Group
Value
95% CI
Rituximab Plus MTX
1.33
± 0.72
Course 1: FU Month 12 (n=39)
Group
Value
95% CI
Rituximab Plus MTX
1.29
± 0.84
Course 2: FU Week 8 (n=100)
Group
Value
95% CI
Rituximab Plus MTX
1.31
± 0.62
Course 2: FU Week 16 (n=104)
Group
Value
95% CI
Rituximab Plus MTX
1.26
± 0.61
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment CourseSecondary· 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
Screening (n=169)
Group
Value
95% CI
Rituximab Plus MTX
20.16
± 11.37
Course 1: FU Week 8 (n=165)
Group
Value
95% CI
Rituximab Plus MTX
18.48
± 11.39
Course 1: FU Week 16 (n=157)
Group
Value
95% CI
Rituximab Plus MTX
18.81
± 12.14
Course 1: FU Week 24 (n=161)
Group
Value
95% CI
Rituximab Plus MTX
17.75
± 11.76
Course 1: FU Month 9 (n=72)
Group
Value
95% CI
Rituximab Plus MTX
18.17
± 12.53
Course 1: FU Month 12 (n=35)
Group
Value
95% CI
Rituximab Plus MTX
20.77
± 13.48
Course 2: FU Week 8 (n=99)
Group
Value
95% CI
Rituximab Plus MTX
16.43
± 11.18
Course 2: FU Week 16 (n=101)
Group
Value
95% CI
Rituximab Plus MTX
16.19
± 11.22
Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment CourseSecondary· 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 genera
Screening (n=171)
Group
Value
95% CI
Rituximab Plus MTX
34.57
± 7.83
Course 1: FU Week 8 (n=165)
Group
Value
95% CI
Rituximab Plus MTX
36.28
± 8.43
Course 1: FU Week 16 (n=160)
Group
Value
95% CI
Rituximab Plus MTX
37.23
± 8.34
Course 1: FU Week 24 (n=161)
Group
Value
95% CI
Rituximab Plus MTX
37.94
± 8.64
Course 1: FU Month 9 (n=74)
Group
Value
95% CI
Rituximab Plus MTX
37.28
± 9.61
Course 1: FU Month 12 (n=39)
Group
Value
95% CI
Rituximab Plus MTX
36.92
± 9.49
Course 2: FU Week 8 (n=102)
Group
Value
95% CI
Rituximab Plus MTX
37.27
± 8.39
Course 2: FU Week 16 (n=105)
Group
Value
95% CI
Rituximab Plus MTX
38.34
± 8.11
SF-36 MCS by Treatment CourseSecondary· 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 genera
Screening (n=171)
Group
Value
95% CI
Rituximab Plus MTX
44.04
± 12.76
Course 1: FU Week 8 (n=165)
Group
Value
95% CI
Rituximab Plus MTX
45.32
± 12.42
Course 1: FU Week 16 (n=160)
Group
Value
95% CI
Rituximab Plus MTX
45.06
± 12.06
Course 1: FU Week 24 (n=161)
Group
Value
95% CI
Rituximab Plus MTX
45.18
± 12.59
Course 1: FU Month 9 (n=74)
Group
Value
95% CI
Rituximab Plus MTX
44.35
± 13.38
Course 1: FU Month 12 (n=39)
Group
Value
95% CI
Rituximab Plus MTX
41.95
± 14.30
Course 2: FU Week 8 (n=102)
Group
Value
95% CI
Rituximab Plus MTX
45.94
± 11.34
Course 2: FU Week 16 (n=105)
Group
Value
95% CI
Rituximab Plus MTX
45.99
± 11.71
SF-36 Domain Scores by Treatment Course - Physical FunctioningSecondary· 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 genera
Screening (n=172)
Group
Value
95% CI
Rituximab Plus MTX
43.26
± 24.74
Course 1: FU Week 8 (n=170)
Group
Value
95% CI
Rituximab Plus MTX
46.80
± 25.20
Course 1: FU Week 16 (n=164)
Group
Value
95% CI
Rituximab Plus MTX
46.85
± 25.16
Course 1: FU Week 24 (n=164)
Group
Value
95% CI
Rituximab Plus MTX
49.58
± 26.45
Course 1: FU Month 9 (n=76)
Group
Value
95% CI
Rituximab Plus MTX
47.30
± 26.17
Course 1: Follow-up Month 12 (n=39)
Group
Value
95% CI
Rituximab Plus MTX
46.92
± 30.21
Course 2: FU Week 8 (n=105)
Group
Value
95% CI
Rituximab Plus MTX
47.17
± 24.51
Course 2: FU Week 16 (n=106)
Group
Value
95% CI
Rituximab Plus MTX
49.03
± 24.91
SF-36 Domain Scores by Treatment Course - Bodily PainSecondary· 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 genera
Screening (n=172)
Group
Value
95% CI
Rituximab Plus MTX
37.22
± 18.00
Course 1: FU Week 8 (n=169)
Group
Value
95% CI
Rituximab Plus MTX
46.06
± 20.62
Course 1: FU Week 16 (n=164)
Group
Value
95% CI
Rituximab Plus MTX
47.98
± 22.29
Course 1: FU Week 24 (n=164)
Group
Value
95% CI
Rituximab Plus MTX
48.70
± 21.39
Course 1: FU Month 9 (n=75)
Group
Value
95% CI
Rituximab Plus MTX
46.55
± 25.29
Course 1: FU Month 12 (n=39)
Group
Value
95% CI
Rituximab Plus MTX
44.10
± 25.24
Course 2: FU Week 8 (n=105)
Group
Value
95% CI
Rituximab Plus MTX
47.15
± 20.93
Course 2: FU Week 16 (n=106)
Group
Value
95% CI
Rituximab Plus MTX
50.34
± 21.60
SF-36 Domain Scores by Treatment Course - Physical Role FunctioningSecondary· 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 genera
Screening (n=173)
Group
Value
95% CI
Rituximab Plus MTX
45.85
± 23.75
Course 1: FU Week 8 (n=170)
Group
Value
95% CI
Rituximab Plus MTX
50.04
± 24.11
Course 1: FU Week 16 (n=166)
Group
Value
95% CI
Rituximab Plus MTX
51.28
± 24.43
Course 1: FU Week 24 (n=165)
Group
Value
95% CI
Rituximab Plus MTX
52.92
± 24.15
Course 1: FU Month 9 (n=76)
Group
Value
95% CI
Rituximab Plus MTX
49.51
± 25.41
Course 1: FU Month 12 (n=39)
Group
Value
95% CI
Rituximab Plus MTX
47.44
± 25.80
Course 2: FU Week 8 (n=103)
Group
Value
95% CI
Rituximab Plus MTX
52.79
± 24.09
Course 2: FU Week 16 (n=106)
Group
Value
95% CI
Rituximab Plus MTX
53.54
± 21.54
SF-36 Domain Scores by Treatment Course - Emotional Role FunctioningSecondary· 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
Screening (n=173)
Group
Value
95% CI
Rituximab Plus MTX
57.80
± 27.52
Course 1: FU Week 8 (n=170)
Group
Value
95% CI
Rituximab Plus MTX
61.91
± 26.27
Course 1: FU Week 16 (n=166)
Group
Value
95% CI
Rituximab Plus MTX
60.44
± 28.06
Course 1: FU Week 24 (n=165)
Group
Value
95% CI
Rituximab Plus MTX
62.12
± 26.87
Course 1: FU Month 9 (n=76)
Group
Value
95% CI
Rituximab Plus MTX
56.52
± 28.52
Course 1: FU Month 12 (n=39)
Group
Value
95% CI
Rituximab Plus MTX
55.98
± 30.82
Course 2: FU Week 8 (n=104)
Group
Value
95% CI
Rituximab Plus MTX
61.30
± 25.41
Course 2: FU Week 16 (n=106)
Group
Value
95% CI
Rituximab Plus MTX
62.74
± 25.28
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rituximab Plus MTX
Serious: 47/193 (24%)
Deaths: —
Serious adverse events (51 terms)
Reaction
System
Rituximab Plus MTX
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
—
Pneumonia
Infections and infestations
—
Respiratory tract infection
Infections and infestations
—
Arthritis
Musculoskeletal and connective tissue disorders
—
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
—
Osteoarthritis
Musculoskeletal and connective tissue disorders
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Coronary artery disease
Cardiac disorders
—
Bronchitis
Infections and infestations
—
Gangrene
Infections and infestations
—
Localised infection
Infections and infestations
—
Nasopharyngitis
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Femoral neck fracture
Injury, poisoning and procedural complications
—
Hip fracture
Injury, poisoning and procedural complications
—
Laceration
Injury, poisoning and procedural complications
—
Radius fracture
Injury, poisoning and procedural complications
—
Hepatic enzyme increased
Investigations
—
Back pain
Musculoskeletal and connective tissue disorders
—
Bursitis
Musculoskeletal and connective tissue disorders
—
Muscular weakness
Musculoskeletal and connective tissue disorders
—
Rheumatoid nodule
Musculoskeletal and connective tissue disorders
—
Synovitis
Musculoskeletal and connective tissue disorders
—
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Other adverse events (170 terms — click to expand)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 18 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00502840.