18 and older, 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.
Health Assessment Questionnaire (HAQ) ScorePrimary· Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Withdrawal Visit is the final visit prior to the withd
Week 0 (n=201)
Group
Value
95% CI
Tocilizumab
1.93
± 0.60
Week 4 (n=199)
Group
Value
95% CI
Tocilizumab
1.49
± 0.65
Week 8 (n=198)
Group
Value
95% CI
Tocilizumab
1.22
± 0.63
Week 12 (n=196)
Group
Value
95% CI
Tocilizumab
1.08
± 0.62
Week 16 (n=193)
Group
Value
95% CI
Tocilizumab
1.00
± 0.60
Week 20 (n=193)
Group
Value
95% CI
Tocilizumab
0.90
± 0.61
Week 24 (n=193)
Group
Value
95% CI
Tocilizumab
0.84
± 0.62
Withdrawal visit (n=6)
Group
Value
95% CI
Tocilizumab
1.32
± 1.13
Pain Score as Assessed by Visual Analogue Scale (VAS)Secondary· Weeks 0, 4, 8, 12, 16, 20, and 24
Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.
Week 0 (n=201)
Group
Value
95% CI
Tocilizumab
63.82
± 16.71
Week 4 (n=199)
Group
Value
95% CI
Tocilizumab
46.36
± 20.57
Week 8 (n=198)
Group
Value
95% CI
Tocilizumab
36.48
± 18.94
Week 12 (n=196)
Group
Value
95% CI
Tocilizumab
31.90
± 19.83
Week 16 (n=193)
Group
Value
95% CI
Tocilizumab
26.92
± 18.87
Week 20 (n=193)
Group
Value
95% CI
Tocilizumab
24.63
± 19.09
Week 24 (n=193)
Group
Value
95% CI
Tocilizumab
21.96
± 18.87
Withdrawal visit (n=6)
Group
Value
95% CI
Tocilizumab
34.50
± 22.00
European Quality of Life - 5 Dimensions (EQ-5D) ScoreSecondary· Weeks 0, 4, 8, 12, 16, 20, and 24
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Week 0 (n=200)
Group
Value
95% CI
Tocilizumab
0.29
± 0.31
Week 4 (n=199)
Group
Value
95% CI
Tocilizumab
0.49
± 0.24
Week 8 (n=198)
Group
Value
95% CI
Tocilizumab
0.57
± 0.20
Week 12 (n=196)
Group
Value
95% CI
Tocilizumab
0.61
± 0.21
Week 16 (n=193)
Group
Value
95% CI
Tocilizumab
0.64
± 0.19
Week 20 (n=193)
Group
Value
95% CI
Tocilizumab
0.66
± 0.18
Week 24 (n=193)
Group
Value
95% CI
Tocilizumab
0.69
± 0.20
Withdrawal visit (n=4)
Group
Value
95% CI
Tocilizumab
0.61
± 0.07
Change in EQ-5D Score at Week 24 From BaselineSecondary· Baseline and Week 24
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessm
Group
Value
95% CI
Tocilizumab
0.41
± 0.33
General Health Score as Assessed by EQ-5D VASSecondary· Weeks 0, 4, 8, 12, 16, 20, and 24
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Week 0 (n=201)
Group
Value
95% CI
Tocilizumab
39.27
± 18.03
Week 4 (n=199)
Group
Value
95% CI
Tocilizumab
50.93
± 18.78
Week 8 (n=198)
Group
Value
95% CI
Tocilizumab
61.79
± 43.45
Week 12 (n=196)
Group
Value
95% CI
Tocilizumab
66.13
± 19.91
Week 16 (n=193)
Group
Value
95% CI
Tocilizumab
70.48
± 19.39
Week 20 (n=192)
Group
Value
95% CI
Tocilizumab
73.31
± 19.58
Week 24 (n=193)
Group
Value
95% CI
Tocilizumab
76.22
± 19.25
Withdrawal visit (n=4)
Group
Value
95% CI
Tocilizumab
60.50
± 27.77
Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5DSecondary· Weeks 0, 4, 8, 12, 16, 20, and 24
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.
Week 4 (n=198)
Group
Value
95% CI
Tocilizumab
42.9
Week 8 (n=198)
Group
Value
95% CI
Tocilizumab
55.6
Week 12 (n=196)
Group
Value
95% CI
Tocilizumab
60.2
Week 16 (n=193)
Group
Value
95% CI
Tocilizumab
65.8
Week 20 (n=193)
Group
Value
95% CI
Tocilizumab
68.4
Week 24 (n=193)
Group
Value
95% CI
Tocilizumab
73.1
Change in General Health Assessed by VASSecondary· Baseline and Week 24
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Group
Value
95% CI
Tocilizumab
37.3
± 25.75
Disease Activity Score Based on 28-Joint Count (DAS28)Secondary· Weeks 0, 4, 8, 12, 16, 20, and 24
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
Week 0 (n=199)
Group
Value
95% CI
Tocilizumab
6.748
± 0.852
Week 4 (n=197)
Group
Value
95% CI
Tocilizumab
4.665
± 1.227
Week 8 (n=196)
Group
Value
95% CI
Tocilizumab
3.777
± 1.279
Week 12 (n=193)
Group
Value
95% CI
Tocilizumab
3.347
± 1.208
Week 16 (n=193)
Group
Value
95% CI
Tocilizumab
2.956
± 1.230
Week 20 (n=192)
Group
Value
95% CI
Tocilizumab
2.762
± 1.111
Week 24 (n=191)
Group
Value
95% CI
Tocilizumab
2.637
± 1.157
Change in DAS28 Score From Baseline to Week 24Secondary· Baseline and Week 24
Group
Value
95% CI
Tocilizumab
4.097
± 1.289
Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab TreatmentPrimary· Weeks 4, 8, 12, 16, 20, and 24
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Week 4 ≥20% (n=199)
Group
Value
95% CI
Tocilizumab
51.8
Week 4 ≥50% (n=199)
Group
Value
95% CI
Tocilizumab
15.6
Week 4 ≥70% (n=199)
Group
Value
95% CI
Tocilizumab
5.0
Week 8 ≥20% (n=198)
Group
Value
95% CI
Tocilizumab
72.2
Week 8 ≥50% (n=198)
Group
Value
95% CI
Tocilizumab
28.8
Week 8 ≥70% (n=198)
Group
Value
95% CI
Tocilizumab
13.6
Week 12 ≥ 20% (n=196)
Group
Value
95% CI
Tocilizumab
83.7
Week 12 ≥50% (n=196)
Group
Value
95% CI
Tocilizumab
42.3
Change in HAQ Score at Week 24Primary· Baseline and Week 24
HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Group
Value
95% CI
Tocilizumab
1.11
± 0.66
Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab TreatmentSecondary· Weeks 0, 4, 8, 12, 16, 20, and 24
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than \[\<\] 2.6), I=low (DAS28 less than or equal to \[≤\]2.6 to \<3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than \[\>\]5.1).
Week 0 moderate activity (n=199)
Group
Value
95% CI
Tocilizumab
2.5
Week 0 high activity (n=199)
Group
Value
95% CI
Tocilizumab
97.5
Week 4 remission (n=197)
Group
Value
95% CI
Tocilizumab
3.0
Week 4 low activity (n=197)
Group
Value
95% CI
Tocilizumab
9.6
Week 4 moderate activity (n=197)
Group
Value
95% CI
Tocilizumab
52.8
Week 4 high activity (n=197)
Group
Value
95% CI
Tocilizumab
34.5
Week 8 remission (n=196)
Group
Value
95% CI
Tocilizumab
17.9
Week 8 low activity (n=196)
Group
Value
95% CI
Tocilizumab
15.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline Visit up to 24 weeks or until withdrawal.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.
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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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 29 March 2018
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/NCT00996203.