Trial Outcomes & Findings for A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis (NCT NCT01941095)

NCT ID: NCT01941095

Last Updated: 2018-11-13

Results Overview

DAS28-ESR score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), patient global assessment of disease activity (PGA) (general health \[GH\]) using visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in millimeters per hour \[mm/hr\]). The score is calculated using the following formula: DAS28-ESR = \[0.56 multiplied by (\*) square root (√) of TJC28\] plus (+) \[0.28\*√SJC28\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score of less than (\<) 2.6 represents DAS28-ESR remission.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

Week 24

Results posted on

2018-11-13

Participant Flow

Participants were enrolled in 9 locations in Greece

A total of 100 participants were enrolled, out of which 97 participants received treatment. Analyses were performed in 97 participants.

Participant milestones

Participant milestones
Measure	Tocilizumab Participants received tocilizumab 162 milligrams (mg) subcutaneous (SC) injection once a week (QW) either as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Overall Study STARTED	97
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	56

Reasons for withdrawal

Reasons for withdrawal
Measure	Tocilizumab Participants received tocilizumab 162 milligrams (mg) subcutaneous (SC) injection once a week (QW) either as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Overall Study Insufficient therapeutic response	13
Overall Study Anaphylaxis or serious hypersensitivity	2
Overall Study Adverse Event	11
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	17
Overall Study Lost to Follow-up	10

Baseline Characteristics

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab n=97 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Age, Continuous	56.27 years STANDARD_DEVIATION 12.77 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Tocilizumab n=80 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Percentage of Participants Who Achieved Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at Week 24	40 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24, 28, 32, 36, 40, 44, 48, 52

Population: Per protocol analysis. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = \[0.56 \* √TJC28 + \[0.28\*√SJC28\]+\[0.70\*ln ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score \<2.6 represents DAS28-ESR remission. The percentage reported for Week 24 is based on confirmation on switching to SC tocilizumab monotherapy.

Outcome measures

Outcome measures
Measure	Tocilizumab n=80 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 Week 24	38.7 percentage of participants
Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 Week 28	34.2 percentage of participants
Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 Week 32	36.5 percentage of participants
Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 Week 36	36.5 percentage of participants
Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 Week 40	36.5 percentage of participants
Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 Week 44	35.2 percentage of participants
Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 Week 48	35.7 percentage of participants
Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 Week 52	38.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 28, 32, 36, 40, 44, 48, 52

Population: Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = \[0.56 \* √TJC28 + \[0.28\*√SJC28\]+\[0.70\*ln ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score \<2.6 represents DAS28-ESR remission. DAS28-ESR score greater than or equal to (\>/=) 2.6 and \<3.2 represents LDA.

Outcome measures

Outcome measures
Measure	Tocilizumab n=79 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 44: LDA	6.9 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 48: LDA	4.2 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 52: LDA	9 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 28: Remission	5.1 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 32: Remission	8.1 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 36: Remission	4.1 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 40: Remission	9.5 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 44: Remission	6.9 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 48: Remission	8.5 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 52: Remission	6 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 28: LDA	7.6 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 32: LDA	1.4 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 36: LDA	6.8 percentage of participants
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24 Week 40: LDA	6.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = \[0.56 \* √TJC28 + \[0.28\*√SJC28\]+\[0.70\*ln ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Tocilizumab n=96 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 2	-0.99 units on a scale Interval -1.33 to -0.64
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 4	-1.70 units on a scale Interval -2.06 to -1.36
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 8	-2.20 units on a scale Interval -2.54 to -1.84
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 12	-2.56 units on a scale Interval -2.91 to -2.2
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 16	-2.59 units on a scale Interval -2.91 to -2.27
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 20	-2.93 units on a scale Interval -3.24 to -2.62
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 24	-3.14 units on a scale Interval -3.45 to -2.83
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 28	-3.22 units on a scale Interval -3.53 to -2.9
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 32	-3.34 units on a scale Interval -3.66 to -3.01
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 36	-3.32 units on a scale Interval -3.64 to -3.0
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 40	-3.40 units on a scale Interval -3.73 to -3.07
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 44	-3.45 units on a scale Interval -3.78 to -3.11
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 48	-3.42 units on a scale Interval -3.76 to -3.08
Change From Baseline in DAS28-ESR up to Week 52 Change at Week 52	-3.40 units on a scale Interval -3.73 to -3.07

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

ACR20 response was defined as \>/=20% improvement from baseline in both TJC28 and SJC28 as well as in 3 out of 5 additional parameters: Separate patient and physician's global assessment of disease activity on VAS (0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS), patient's assessment of pain on VAS (0 mm=no pain to 100 mm=unbearable pain, displayed on the 100 mm horizontal VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI) (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without any difficulty to 3=unable to do), and acute phase response (ESR in mm/hr, for a total possible score of 0 to 10).

Outcome measures

Outcome measures
Measure	Tocilizumab n=96 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 2	19 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 4	19 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 8	23 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 12	9 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 16	13 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 20	16 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 24	9 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 28	13 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 32	10 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 36	11 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 40	10 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 44	12 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 48	13 participants
Number of Participants With American College of Rheumatology 20 (ACR20) Response Week 52	15 participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Response to treatment was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the baseline visit. Participants with a score lesser than or equal to (\</=) 3.2 and reduction of greater than (\>) 1.2 points were assessed as having a 'good' response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score \</=5.1 with reduction of \>0.6 to \</=1.2 points, were assessed as having a 'moderate' response. Participants with a score \>5.1 with reduction of \>0.6 to \</=1.2 points, or any score with reduction \</=0.6 points, were assessed as having 'no response'.

Outcome measures

Outcome measures
Measure	Tocilizumab n=96 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 2: Good response	9.4 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 2: Moderate response	44.8 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 2: No response	45.8 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 4: Good response	9.5 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 4: Moderate response	38.9 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 4: No response	51.6 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 8: Good response	10.8 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 8: Moderate response	23.6 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 8: No response	65.6 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 12: Good response	9.2 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 12: Moderate response	20.7 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 12: No response	70.1 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 16: Good response	5.9 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 16: Moderate response	15.3 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 16: No response	78.8 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 20: Good response	6.1 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 20: Moderate response	26.8 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 20: No response	67.1 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 24: Good response	6.2 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 24: Moderate response	21.2 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 24: No response	72.6 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 28: Good response	6.3 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 28: Moderate response	11.4 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 28: No response	82.3 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 32: Good response	0 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 32: Moderate response	18.9 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 32: No response	81.1 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 36: Good response	1.3 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 36: Moderate response	14.9 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 36: No response	83.8 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 40: Good response	5.4 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 40: Moderate response	17.6 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 40: No response	77 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 44: Good response	2.8 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 44: Moderate response	13.9 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 44: No response	83.3 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 48: Good response	5.7 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 48: Moderate response	11.4 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 48: No response	82.9 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 52: Good response	94 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 52: Moderate response	6 percentage of participants
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria Week 52: No response	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

SDAI is an index for measuring disease activity. SDAI is the numerical sum of five outcome parameters: TJC28 and SJC28, PGA and physician global assessment of disease activity assessed on VAS (0 centimeter \[cm\]-10 cm); 0 cm= no disease activity and 10 cm= worst disease activity, and CRP (in milligrams per deciliter \[mg/dL\]). SDAI total score ranges from 0 to 86, with higher scores indicating increased (or severe) disease activity. SDAI score \</=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab n=96 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 2	-3.41 units on a scale Interval -7.17 to 0.12
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 4	-6.54 units on a scale Interval -10.26 to -2.97
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 8	-8.72 units on a scale Interval -12.89 to -5.18
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 12	-11.07 units on a scale Interval -14.74 to -8.04
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 16	-13.47 units on a scale Interval -17.0 to -10.6
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 20	-13.88 units on a scale Interval -17.42 to -10.94
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 24	-14.08 units on a scale Interval -17.72 to -11.25
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 28	-15.37 units on a scale Interval -18.87 to -12.41
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 32	-16.09 units on a scale Interval -19.63 to -13.07
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 36	-15.61 units on a scale Interval -19.14 to -12.58
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 40	-14.86 units on a scale Interval -18.66 to -11.84
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 44	-16.31 units on a scale Interval -20.06 to -13.24
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 48	-16.47 units on a scale Interval -20.13 to -13.45
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 Change at Week 52	-17.35 units on a scale Interval -21.01 to -14.16

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

28 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A negative change from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Tocilizumab n=96 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Change From Baseline in TJC28 up to Week 52 Change at Week 2	-1.30 tender joints Interval -3.18 to 0.56
Change From Baseline in TJC28 up to Week 52 Change at Week 4	-3.26 tender joints Interval -5.09 to -1.42
Change From Baseline in TJC28 up to Week 52 Change at Week 8	-4.97 tender joints Interval -6.69 to -3.25
Change From Baseline in TJC28 up to Week 52 Change at Week 12	-5.82 tender joints Interval -7.55 to -4.09
Change From Baseline in TJC28 up to Week 52 Change at Week 16	-6.39 tender joints Interval -8.08 to -4.7
Change From Baseline in TJC28 up to Week 52 Change at Week 20	-7.03 tender joints Interval -8.67 to -5.38
Change From Baseline in TJC28 up to Week 52 Change at Week 24	-7.72 tender joints Interval -9.34 to -6.09
Change From Baseline in TJC28 up to Week 52 Change at Week 28	-7.91 tender joints Interval -9.51 to -6.31
Change From Baseline in TJC28 up to Week 52 Change at Week 32	-8.38 tender joints Interval -10.0 to -6.77
Change From Baseline in TJC28 up to Week 52 Change at Week 36	-8.28 tender joints Interval -9.86 to -6.66
Change From Baseline in TJC28 up to Week 52 Change at Week 40	-8.22 tender joints Interval -9.84 to -6.59
Change From Baseline in TJC28 up to Week 52 Change at Week 44	-8.63 tender joints Interval -10.25 to -7.01
Change From Baseline in TJC28 up to Week 52 Change at Week 48	-8.26 tender joints Interval -9.97 to -6.54
Change From Baseline in TJC28 up to Week 52 Change at Week 52	-8.75 tender joints Interval -10.41 to -7.09

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

28 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A negative change from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Tocilizumab n=96 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Change From Baseline in SJC28 up to Week 52 Change at Week 20	-6.06 swollen joints Interval -7.55 to -4.57
Change From Baseline in SJC28 up to Week 52 Change at Week 2	-1.82 swollen joints Interval -3.51 to -0.13
Change From Baseline in SJC28 up to Week 52 Change at Week 4	-3.08 swollen joints Interval -4.7 to -1.46
Change From Baseline in SJC28 up to Week 52 Change at Week 8	-4.71 swollen joints Interval -6.2 to -3.21
Change From Baseline in SJC28 up to Week 52 Change at Week 12	-5.24 swollen joints Interval -6.68 to -3.79
Change From Baseline in SJC28 up to Week 52 Change at Week 16	-5.79 swollen joints Interval -7.27 to -4.31
Change From Baseline in SJC28 up to Week 52 Change at Week 24	-6.60 swollen joints Interval -8.03 to -5.18
Change From Baseline in SJC28 up to Week 52 Change at Week 28	-6.65 swollen joints Interval -8.09 to -5.21
Change From Baseline in SJC28 up to Week 52 Change at Week 32	-6.73 swollen joints Interval -8.19 to -5.27
Change From Baseline in SJC28 up to Week 52 Change at Week 36	-6.76 swollen joints Interval -8.22 to -5.28
Change From Baseline in SJC28 up to Week 52 Change at Week 40	-6.91 swollen joints Interval -8.37 to -5.44
Change From Baseline in SJC28 up to Week 52 Change at Week 44	-6.82 swollen joints Interval -8.31 to -5.33
Change From Baseline in SJC28 up to Week 52 Change at Week 48	-6.63 swollen joints Interval -8.15 to -5.1
Change From Baseline in SJC28 up to Week 52 Change at Week 52	-6.98 swollen joints Interval -8.52 to -5.44

SECONDARY outcome

Timeframe: From Baseline up to Week 52

Population: Full analysis set. Overall number of participants analyzed = participants who used corticosteroids during the study.

Outcome measures

Outcome measures
Measure	Tocilizumab n=37 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Percentage of Participants With Corticosteroid Dose Reduction or Discontinuation	48.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline up to Week 52

Population: Full analysis set. Overall number of participants analyzed = participants with corticosteroid dose reduction/discontinuation.

Reasons for corticosteroid dose reduction included: Safety Reasons (including elevated liver function test results, respiratory infections, infections and infestations, gastrointestinal disorders etc.); Other Reasons (disease remission, improvement etc.); and Unknown Reasons (including no reason). Number of participants by reasons (Safety, Other, Unknown) for corticosteroid dose reduction or discontinuation were reported.

Outcome measures

Outcome measures
Measure	Tocilizumab n=18 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Number of Participants by Reasons (Categories) for Corticosteroid Dose Reduction or Discontinuation Safety	6 participants
Number of Participants by Reasons (Categories) for Corticosteroid Dose Reduction or Discontinuation Other	10 participants
Number of Participants by Reasons (Categories) for Corticosteroid Dose Reduction or Discontinuation Unknown	2 participants

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 12, 24, 36, 52, and 8 weeks after Week 52 dose (Week 60)

Population: Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

All samples were tested using a screening assay and, if positive, by a confirmation assay to determine specificity and a neutralizing assay to test for the ability to inhibit the activity of tocilizumab. Number of participants with a positive assay result for screening assay (ATA - Screen), confirmatory assay (ATA - Confirmatory), and neutralizing assay (ATA - Neutralizing) was reported separately.

Outcome measures

Outcome measures
Measure	Tocilizumab n=97 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 1: ATA - Screen	7 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 1: ATA - Confirmatory	4 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 1: ATA - Neutralizing	0 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 12: ATA - Screen	3 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 12: ATA - Confirmatory	0 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 12: ATA - Neutralizing	0 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 24: ATA - Screen	3 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 24: ATA - Confirmatory	1 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 24: ATA - Neutralizing	1 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 36: ATA - Screen	2 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 36: ATA - Confirmatory	0 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 36: ATA - Neutralizing	0 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 52: ATA - Screen	2 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 52: ATA - Confirmatory	0 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 52: ATA - Neutralizing	0 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 60: ATA - Screen	1 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 60: ATA - Confirmatory	1 participants
Number of Participants With Anti-Tocilizumab Antibodies (ATA) Week 60: ATA - Neutralizing	0 participants

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 12, 24, 36, 52, and 8 weeks after Week 52 dose (Week 60)

Population: Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

Outcome measures

Outcome measures
Measure	Tocilizumab n=97 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Soluble Interleukin-6 Receptor (sIL-6R) Levels Week 1	39450 nanograms per milliliter (ng/mL) Standard Deviation 10740
Soluble Interleukin-6 Receptor (sIL-6R) Levels Week 12	553.43 nanograms per milliliter (ng/mL) Standard Deviation 120.36
Soluble Interleukin-6 Receptor (sIL-6R) Levels Week 24	572.03 nanograms per milliliter (ng/mL) Standard Deviation 136.68
Soluble Interleukin-6 Receptor (sIL-6R) Levels Week 36	570.78 nanograms per milliliter (ng/mL) Standard Deviation 139.16
Soluble Interleukin-6 Receptor (sIL-6R) Levels Week 52	537.73 nanograms per milliliter (ng/mL) Standard Deviation 152.55
Soluble Interleukin-6 Receptor (sIL-6R) Levels Week 60	42850 nanograms per milliliter (ng/mL) Standard Deviation 13800

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 12, 24, 36, 52, and 8 weeks after Week 52 dose (Week 60)

Population: Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

Outcome measures

Outcome measures
Measure	Tocilizumab n=97 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Tocilizumab Serum Levels Week 52	45.37 microgrms per milliliter (mcg/mL) Standard Deviation 28.13
Tocilizumab Serum Levels Week 1	0.38 microgrms per milliliter (mcg/mL) Standard Deviation 0.17
Tocilizumab Serum Levels Week 12	41.98 microgrms per milliliter (mcg/mL) Standard Deviation 25.04
Tocilizumab Serum Levels Week 24	44.67 microgrms per milliliter (mcg/mL) Standard Deviation 28.83
Tocilizumab Serum Levels Week 36	47.90 microgrms per milliliter (mcg/mL) Standard Deviation 28.29
Tocilizumab Serum Levels Week 60	6.46 microgrms per milliliter (mcg/mL) Standard Deviation 4.28

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Population: Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

PGA was assessed on a 0 to 100 mm horizontal VAS. The extreme left end of the line = 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end = 100 mm, and was described as "maximum disease activity" (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity).

Outcome measures

Outcome measures
Measure	Tocilizumab n=97 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
PGA, Using VAS Score Week 1	28.26 mm Standard Deviation 20.25
PGA, Using VAS Score Week 2	27.57 mm Standard Deviation 20.08
PGA, Using VAS Score Week 4	28.36 mm Standard Deviation 19.37
PGA, Using VAS Score Week 8	32.28 mm Standard Deviation 22.09
PGA, Using VAS Score Week 12	28.73 mm Standard Deviation 23.01
PGA, Using VAS Score Week 16	24.40 mm Standard Deviation 19.02
PGA, Using VAS Score Week 20	28.15 mm Standard Deviation 20.22
PGA, Using VAS Score Week 24	32.63 mm Standard Deviation 23.44
PGA, Using VAS Score Week 28	26.02 mm Standard Deviation 18.79
PGA, Using VAS Score Week 32	27.08 mm Standard Deviation 20.98
PGA, Using VAS Score Week 36	30.79 mm Standard Deviation 22.37
PGA, Using VAS Score Week 40	30.50 mm Standard Deviation 21.93
PGA, Using VAS Score Week 44	25.79 mm Standard Deviation 16.33
PGA, Using VAS Score Week 48	23.86 mm Standard Deviation 19.11
PGA, Using VAS Score Week 52	23.08 mm Standard Deviation 17.08

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Population: Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

The participant's level of pain was assessed on a 0 to 100 mm horizontal VAS. The extreme left end of the line = 0 mm, and was described as "no pain" and the extreme right end = 100 mm, and was described as "unbearable pain". Higher values correspond to worst state of participant (higher level of pain).

Outcome measures

Outcome measures
Measure	Tocilizumab n=97 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Patient Assessment of Pain, Using VAS Score Week 1	46.40 mm Standard Deviation 27.43
Patient Assessment of Pain, Using VAS Score Week 2	52.04 mm Standard Deviation 24.46
Patient Assessment of Pain, Using VAS Score Week 4	49.87 mm Standard Deviation 23.35
Patient Assessment of Pain, Using VAS Score Week 8	42.72 mm Standard Deviation 23.20
Patient Assessment of Pain, Using VAS Score Week 12	37.21 mm Standard Deviation 21.29
Patient Assessment of Pain, Using VAS Score Week 16	34.24 mm Standard Deviation 22.49
Patient Assessment of Pain, Using VAS Score Week 20	31.00 mm Standard Deviation 19.42
Patient Assessment of Pain, Using VAS Score Week 24	29.57 mm Standard Deviation 19.66
Patient Assessment of Pain, Using VAS Score Week 28	29.63 mm Standard Deviation 19.07
Patient Assessment of Pain, Using VAS Score Week 32	25.50 mm Standard Deviation 17.95
Patient Assessment of Pain, Using VAS Score Week 36	26.78 mm Standard Deviation 22.13
Patient Assessment of Pain, Using VAS Score Week 40	27.50 mm Standard Deviation 21.93
Patient Assessment of Pain, Using VAS Score Week 44	26.88 mm Standard Deviation 19.96
Patient Assessment of Pain, Using VAS Score Week 48	23.61 mm Standard Deviation 18.63
Patient Assessment of Pain, Using VAS Score Week 52	23.98 mm Standard Deviation 20.19

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Population: Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set were scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person was required. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent "mild to moderate difficulty", 1 to 2 as "moderate to severe disability", and 2 to 3 as "severe to very severe disability".

Outcome measures

Outcome measures
Measure	Tocilizumab n=97 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
HAQ-DI Score Week 1	1.31 units on a scale Standard Deviation 0.66
HAQ-DI Score Week 2	1.22 units on a scale Standard Deviation 0.64
HAQ-DI Score Week 4	1.09 units on a scale Standard Deviation 0.66
HAQ-DI Score Week 8	0.91 units on a scale Standard Deviation 0.66
HAQ-DI Score Week 12	0.82 units on a scale Standard Deviation 0.58
HAQ-DI Score Week 16	0.72 units on a scale Standard Deviation 0.59
HAQ-DI Score Week 20	0.68 units on a scale Standard Deviation 0.56
HAQ-DI Score Week 24	0.66 units on a scale Standard Deviation 0.55
HAQ-DI Score Week 28	0.66 units on a scale Standard Deviation 0.57
HAQ-DI Score Week 32	0.59 units on a scale Standard Deviation 0.58
HAQ-DI Score Week 36	0.63 units on a scale Standard Deviation 0.58
HAQ-DI Score Week 40	0.60 units on a scale Standard Deviation 0.59
HAQ-DI Score Week 44	0.59 units on a scale Standard Deviation 0.61
HAQ-DI Score Week 48	0.56 units on a scale Standard Deviation 0.59
HAQ-DI Score Week 52	0.54 units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Population: Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

Compliance (in terms of percentage of participants who received all planned study medication) was assessed on the basis of participant diary cards and return records.

Outcome measures

Outcome measures
Measure	Tocilizumab n=97 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 1	66 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 2	97.9 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 4	100 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 8	100 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 12	98.9 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 16	97.6 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 20	98.8 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 24	100 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 28	100 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 32	100 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 36	100 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 40	100 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 44	100 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 48	100 percentage of participants
Percentage of Participants Who Received All Planned Study Medication (Compliance) Week 52	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52

Population: Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.

FACIT-Fatigue total score is sum of FACIT-General subscale score and FACIT-Fatigue (additional concerns) subscale score. FACT-General consists of 27 questions grouped in 4 domains of general health-related quality of life: physical well-being, social/family well-being, emotional well-being, and functional well-being; each item ranges from 0 (not at all) to 4 (very much). FACT-General score ranges between 0-108. FACIT-Fatigue subscale is a 13-item questionnaire that evaluates self-reported fatigue and its impact upon daily activities. Each item ranges from 0 (Not at all) to 4 (Very much). For all items, 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 subscale score for a total possible score of 0 (worse score) to 52 (better score). FACIT-Fatigue total score (FACT-G plus FACT-F subscale scores) ranges from 0 (better score) to 160 (worse score).

Outcome measures

Outcome measures
Measure	Tocilizumab n=97 Participants Participants received tocilizumab 162 mg SC injection QW either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 4	100.38 units on a scale Standard Deviation 24.36
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 2	91.83 units on a scale Standard Deviation 22.91
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 8	103.16 units on a scale Standard Deviation 26.28
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 12	106.39 units on a scale Standard Deviation 24.74
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 1	89.68 units on a scale Standard Deviation 24.32
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 16	110.17 units on a scale Standard Deviation 24.96
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 20	112.60 units on a scale Standard Deviation 25.50
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 24	114.21 units on a scale Standard Deviation 25.23
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 28	114.85 units on a scale Standard Deviation 26.95
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 32	117.01 units on a scale Standard Deviation 26.00
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 36	116.50 units on a scale Standard Deviation 26.17
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 40	116.59 units on a scale Standard Deviation 26.20
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 44	119.67 units on a scale Standard Deviation 26.64
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 48	119.83 units on a scale Standard Deviation 26.51
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score Week 52	121.82 units on a scale Standard Deviation 25.34

Adverse Events

Tocilizumab Monotherapy

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Tocilizumab + Methotrexate or Other Non-Biologic DMARDs

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tocilizumab Monotherapy n=31 participants at risk Participants received tocilizumab 162 mg SC injection QW as monotherapy during the treatment period of 52 weeks.	Tocilizumab + Methotrexate or Other Non-Biologic DMARDs n=66 participants at risk Participants received tocilizumab 162 mg SC injection QW in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks.
Cardiac disorders Acute coronary syndrome	0.00% 0/31 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.	1.5% 1/66 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/31 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.	1.5% 1/66 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.
Gastrointestinal disorders Diarrhoea	3.2% 1/31 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.	1.5% 1/66 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.
Infections and infestations Bronchitis	0.00% 0/31 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.	1.5% 1/66 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.
Infections and infestations Respiratory tract infection	3.2% 1/31 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.	0.00% 0/66 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.
Metabolism and nutrition disorders Dehydration	3.2% 1/31 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.	0.00% 0/66 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/31 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.	3.0% 2/66 • From Baseline up to end of study (Week 60) Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

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