Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy (NCT NCT01362062)
NCT ID: NCT01362062
Last Updated: 2017-08-02
Results Overview
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal product. An AE is considered as an SAE if it fulfills one of the following criteria: a) fatal or life-threatening, b) requires in-patient hospitalization or prolongation of existing hospitalization, c) results in a persistent or significant disability, d) results in a congenital abnormality/birth defect, e) is medically significant. AEs included serious as well as non-serious AEs.
Recruitment status
COMPLETED
Target enrollment
110 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2017-08-02
Participant Flow
Participant milestones
| Measure |
RA Cohort (Prospective)
Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
|
RA Cohort (Retrospective)
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
62
|
|
Overall Study
COMPLETED
|
22
|
62
|
|
Overall Study
NOT COMPLETED
|
26
|
0
|
Reasons for withdrawal
| Measure |
RA Cohort (Prospective)
Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
|
RA Cohort (Retrospective)
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
11
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Non-compliant participant
|
2
|
0
|
|
Overall Study
Detected with Spondylo-arthritis
|
1
|
0
|
|
Overall Study
Had significant improvement
|
9
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy
Baseline characteristics by cohort
| Measure |
RA Cohort (Prospective)
n=48 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
|
RA Cohort (Retrospective)
n=62 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.19 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
50.39 years
STANDARD_DEVIATION 12.56 • n=7 Participants
|
50.74 years
STANDARD_DEVIATION 11.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Safety analysis population: Included all participants who received at least 1 dose of study drug.
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal product. An AE is considered as an SAE if it fulfills one of the following criteria: a) fatal or life-threatening, b) requires in-patient hospitalization or prolongation of existing hospitalization, c) results in a persistent or significant disability, d) results in a congenital abnormality/birth defect, e) is medically significant. AEs included serious as well as non-serious AEs.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=110 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
AEs
|
31.8 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
SAEs
|
7.2 percentage of participants
|
SECONDARY outcome
Timeframe: Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)Population: Efficacy analysis population included participants who were observed prospectively in this study. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.
DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, erythrocyte sedimentation rate (ESR) (in millimeters \[mm\]/hour), and the participant's global assessment of disease activity (100 mm visual analog scale \[VAS\]: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*square root (√) of TJC + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=43 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 4 (n=37)
|
73.0 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 5 (n=37)
|
81.1 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 7 (n=39)
|
84.6 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 9 (n=20)
|
85.0 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 10 (n=18)
|
88.9 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 13 (n=17)
|
94.1 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 3 (n=38)
|
55.3 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 6 (n=36)
|
80.6 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 8 (n=21)
|
90.5 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 11 (n=23)
|
87.0 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Visit 12 (n=20)
|
95.0 percentage of participants
|
|
Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit
Overall (n=43)
|
97.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement. Time taken to achieve clinically meaningful improvement in DAS28 was reported.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=43 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Time Required to Achieve Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
|
60 days
Interval 28.0 to 252.0
|
SECONDARY outcome
Timeframe: Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)Population: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low Disease Activity is defined as DAS28 value of \<3.2 Units at the time of assessment.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=43 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 3 (n=38)
|
15.8 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 12 (n=20)
|
70.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 4 (n=37)
|
27.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 5 (n=37)
|
29.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 6 (n=36)
|
44.4 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 7 (n=39)
|
46.2 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 8 (n=21)
|
42.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 9 (n=20)
|
45.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 10 (n=18)
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 11 (n=23)
|
60.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Visit 13 (n=17)
|
64.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit
Overall (n=43)
|
74.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity is defined as decrease in DAS28 to a value \<3.2 Units at the time of assessment. Time taken to achieve low disease activity was reported.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=43 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Time Required to Achieve Low Disease Activity (DAS28 <3.2 Units)
|
117.25 days
Interval 28.0 to 252.0
|
SECONDARY outcome
Timeframe: Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)Population: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of \<2.6 units at the time of assessment.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=43 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 3 (n=38)
|
5.3 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 5 (n=37)
|
16.2 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 6 (n=36)
|
30.6 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 7 (n=39)
|
35.9 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 9 (n=20)
|
35.0 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 10 (n=18)
|
38.9 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 13 (n=17)
|
58.8 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Overall (n=43)
|
60.5 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 4 (n=37)
|
10.8 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 8 (n=21)
|
28.6 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 11 (n=23)
|
52.2 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit
Visit 12 (n=20)
|
55.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.
DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56\*√(TJC) + 0.28\*√(SJC) + 0.70\*log natural (ESR) + 0.014\*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of \<2.6 units at the time of assessment. Time taken to achieve remission is reported.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=43 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Time Taken to Achieve Remission (DAS28 <2.6 Units)
|
130.31 days
Interval 28.0 to 252.0
|
SECONDARY outcome
Timeframe: Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 42), Visit 13 (Week 44)Population: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.
ACR20/ACR50/ACR70/ACR 90 response: greater than or equal to (≥) 20%/50%/70%/90% improvement in tender and swollen joint counts and 20%/50%/70%/90% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) Participant assessment of disease activity, 3) Participant assessment of pain (VAS), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) ESR at each visit.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=33 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 3: ACR 90 response (n=29)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 4: ACR 20 response (n=33)
|
75.8 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 5: ACR 20 response (n=28)
|
53.6 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 6: ACR 90 response (n=31)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 7: ACR 20 response (n=30)
|
36.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 8: ACR 90 response (n=17)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 9: ACR 20 response (n=16)
|
18.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 10: ACR 50 response (n=12)
|
33.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 10: ACR 70 response (n=12)
|
33.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 10: ACR 90 response (n=12)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 11: ACR 70 response (n=17)
|
47.1 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 11: ACR 90 response (n=17)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 12: ACR 90 response (n=15)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 13: ACR 20 response (n=11)
|
9.1 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 13: ACR 70 response (n=11)
|
63.6 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 3: ACR 20 response (n=29)
|
86.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 3: ACR 50 response (n=29)
|
10.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 3: ACR 70 response (n=29)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 4: ACR 50 response (n=33)
|
18.2 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 4: ACR 70 response (n=33)
|
3.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 4: ACR 90 response (n=33)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 5: ACR 50 response (n=28)
|
28.6 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 5: ACR 70 response (n=28)
|
14.2 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 5: ACR 90 response (n=28)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 6: ACR 20 response (n=31)
|
41.9 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 6: ACR 50 response (n=31)
|
35.5 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 6: ACR 70 response (n=31)
|
22.6 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 7: ACR 50 response (n=30)
|
26.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 7: ACR 70 response (n=30)
|
30.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 7: ACR 90 response (n=30)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 8: ACR 20 response (n=17)
|
52.9 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 8: ACR 50 response (n=17)
|
23.5 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 8: ACR 70 response (n=17)
|
17.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 9: ACR 50 response (n=16)
|
56.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 9: ACR 70 response (n=16)
|
25.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 9: ACR 90 response (n=16)
|
0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 10: ACR 20 response (n=12)
|
33.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 11: ACR 20 response (n=17)
|
29.4 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 11: ACR 50 response (n=17)
|
23.5 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 12: ACR 20 response (n=15)
|
13.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 12: ACR 50 response (n=15)
|
46.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 12: ACR 70 response (n=15)
|
40.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 13: ACR 50 response (n=11)
|
27.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit
Visit 13: ACR 90 response (n=11)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)Population: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=27 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 3
|
-34.03 mm/hour
Standard Deviation 30.87
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 4
|
-39.63 mm/hour
Standard Deviation 31.40
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 6
|
-38.71 mm/hour
Standard Deviation 30.26
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 7
|
-41.66 mm/hour
Standard Deviation 33.23
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 8
|
-39.07 mm/hour
Standard Deviation 34.08
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 9
|
-33.26 mm/hour
Standard Deviation 37.61
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 10
|
-35.89 mm/hour
Standard Deviation 35.81
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 11
|
-37.52 mm/hour
Standard Deviation 32.42
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 12
|
-40.37 mm/hour
Standard Deviation 35.38
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 13
|
-38.70 mm/hour
Standard Deviation 35.32
|
|
Change From Baseline (CFB) in ESR Values at Every Visit
CFB at Visit 5
|
-38.03 mm/hour
Standard Deviation 32.07
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)Population: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=17 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 3
|
-12.34 milligrams per deciliter (mg/dL)
Standard Deviation 14.48
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 4
|
-12.82 milligrams per deciliter (mg/dL)
Standard Deviation 16.24
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 5
|
-13.77 milligrams per deciliter (mg/dL)
Standard Deviation 15.26
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 6
|
-12.15 milligrams per deciliter (mg/dL)
Standard Deviation 18.24
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 7
|
-16.51 milligrams per deciliter (mg/dL)
Standard Deviation 15.57
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 8
|
-13.92 milligrams per deciliter (mg/dL)
Standard Deviation 18.98
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 9
|
-12.79 milligrams per deciliter (mg/dL)
Standard Deviation 19.17
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 10
|
-13.24 milligrams per deciliter (mg/dL)
Standard Deviation 18.53
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 11
|
-14.74 milligrams per deciliter (mg/dL)
Standard Deviation 14.70
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 12
|
-16.65 milligrams per deciliter (mg/dL)
Standard Deviation 15.17
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit
CFB at Visit 13
|
-15.69 milligrams per deciliter (mg/dL)
Standard Deviation 14.97
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)Population: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.
The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=41 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 13
|
-30.34 millimeters
Standard Deviation 37.86
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 3
|
-11.34 millimeters
Standard Deviation 21.97
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 4
|
-18.67 millimeters
Standard Deviation 26.29
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 5
|
-17.86 millimeters
Standard Deviation 33.62
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 6
|
-24.51 millimeters
Standard Deviation 35.40
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 7
|
-25.90 millimeters
Standard Deviation 36.66
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 8
|
-27.20 millimeters
Standard Deviation 37.13
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 9
|
-28.17 millimeters
Standard Deviation 37.50
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 10
|
-27.25 millimeters
Standard Deviation 37.07
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 11
|
-30.71 millimeters
Standard Deviation 39.16
|
|
Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 12
|
-30.42 millimeters
Standard Deviation 38.13
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)Population: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.
The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as "maximum disease activity" (maximum arthritis disease activity).
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=41 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 3
|
-17.78 millimeters
Standard Deviation 19.72
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 4
|
-23.56 millimeters
Standard Deviation 24.64
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 5
|
-23.85 millimeters
Standard Deviation 33.00
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 6
|
-29.06 millimeters
Standard Deviation 33.91
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 7
|
-27.22 millimeters
Standard Deviation 34.90
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 8
|
-29.00 millimeters
Standard Deviation 35.51
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 9
|
-29.86 millimeters
Standard Deviation 36.32
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 10
|
-28.68 millimeters
Standard Deviation 35.95
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 11
|
-32.51 millimeters
Standard Deviation 37.57
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 12
|
-32.10 millimeters
Standard Deviation 36.58
|
|
Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 13
|
-32.64 millimeters
Standard Deviation 36.93
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)Population: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.
The participant assessed their pain on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm, and is described as "unbearable pain". A negative change indicated improvement.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=35 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 11
|
-33.88 millimeters
Standard Deviation 30.19
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 12
|
-33.71 millimeters
Standard Deviation 28.25
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 13
|
-33.63 millimeters
Standard Deviation 28.33
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 3
|
-13.66 millimeters
Standard Deviation 19.43
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 4
|
-20.93 millimeters
Standard Deviation 22.23
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 5
|
-21.14 millimeters
Standard Deviation 26.46
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 6
|
-26.34 millimeters
Standard Deviation 27.32
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 7
|
-29.32 millimeters
Standard Deviation 27.19
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 8
|
-29.75 millimeters
Standard Deviation 27.97
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 9
|
-31.10 millimeters
Standard Deviation 28.21
|
|
Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit
CFB at Visit 10
|
-30.17 millimeters
Standard Deviation 27.83
|
SECONDARY outcome
Timeframe: Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)Population: Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.
HAQ-DI is a self-completed patient questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The HAQ-DI is the sum of the scores from all domains and ranged from 0 (best) to 24 (worst). A negative change from baseline indicated improvement.
Outcome measures
| Measure |
RA Cohort (Prospective + Retrospective)
n=35 Participants
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 3
|
-02.40 units on scale
Standard Deviation 09.08
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 4
|
-02.21 units on scale
Standard Deviation 10.20
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 5
|
-03.79 units on scale
Standard Deviation 13.43
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 10
|
-03.11 units on scale
Standard Deviation 10.76
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 6
|
-03.85 units on scale
Standard Deviation 12.94
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 7
|
-04.05 units on scale
Standard Deviation 10.67
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 8
|
-03.92 units on scale
Standard Deviation 11.16
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 9
|
-03.90 units on scale
Standard Deviation 11.68
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 11
|
-04.28 units on scale
Standard Deviation 12.40
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 12
|
-04.35 units on scale
Standard Deviation 12.38
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit
CFB at Visit 13
|
-04.39 units on scale
Standard Deviation 12.37
|
Adverse Events
RA Cohort (Prospective + Retrospective)
Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RA Cohort (Prospective + Retrospective)
n=110 participants at risk
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.91%
1/110 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.8%
2/110 • Up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.91%
1/110 • Up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.91%
1/110 • Up to 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.91%
1/110 • Up to 12 months
|
|
Infections and infestations
Acute Gastroenteritis
|
0.91%
1/110 • Up to 12 months
|
|
Infections and infestations
Tuberculosis of Vertebral Column
|
0.91%
1/110 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.91%
1/110 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.91%
1/110 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Hip Arthroplasty
|
0.91%
1/110 • Up to 12 months
|
|
Nervous system disorders
Motor Peripheral Neuropathy
|
0.91%
1/110 • Up to 12 months
|
Other adverse events
| Measure |
RA Cohort (Prospective + Retrospective)
n=110 participants at risk
Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
|
|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
5.5%
6/110 • Up to 12 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.91%
1/110 • Up to 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.91%
1/110 • Up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.91%
1/110 • Up to 12 months
|
|
Eye disorders
Eye Inflammation
|
0.91%
1/110 • Up to 12 months
|
|
Eye disorders
Eye Swelling
|
0.91%
1/110 • Up to 12 months
|
|
General disorders
Fever
|
1.8%
2/110 • Up to 12 months
|
|
General disorders
General Body Pain
|
0.91%
1/110 • Up to 12 months
|
|
General disorders
Redness
|
0.91%
1/110 • Up to 12 months
|
|
General disorders
Swelling Face
|
0.91%
1/110 • Up to 12 months
|
|
General disorders
Rash
|
3.6%
4/110 • Up to 12 months
|
|
Metabolism and nutrition disorders
Oedema Peripheral
|
0.91%
1/110 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Limb
|
0.91%
1/110 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Painful Joints
|
0.91%
1/110 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.91%
1/110 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
0.91%
1/110 • Up to 12 months
|
|
Infections and infestations
Acute Gastroenteritis
|
1.8%
2/110 • Up to 12 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.91%
1/110 • Up to 12 months
|
|
Infections and infestations
Application Site Pustules
|
0.91%
1/110 • Up to 12 months
|
|
Investigations
Transaminitis
|
0.91%
1/110 • Up to 12 months
|
|
Investigations
Liver Enzyme Abnormal
|
0.91%
1/110 • Up to 12 months
|
|
Investigations
Lipids Increased
|
0.91%
1/110 • Up to 12 months
|
|
Investigations
Weight Gain
|
0.91%
1/110 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Generalized Itching
|
0.91%
1/110 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Itching
|
4.5%
5/110 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Urticarial Rash
|
1.8%
2/110 • Up to 12 months
|
|
Nervous system disorders
Parasthesia
|
0.91%
1/110 • Up to 12 months
|
|
Nervous system disorders
Giddiness
|
1.8%
2/110 • Up to 12 months
|
|
Nervous system disorders
Insomnia
|
0.91%
1/110 • Up to 12 months
|
|
Reproductive system and breast disorders
Per Vaginal Bleeding
|
0.91%
1/110 • Up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER