Trial Outcomes & Findings for A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy (NCT NCT02001987)

Results Overview

The DAS28-ESR was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and Patient Global Assessment of disease activity (PGA) according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was averaged among all participants, where negative changes indicated an improvement in disease activity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

139 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2018-11-02

Participant Flow

A total of 183 participants were screened; 139 participants were eligible for the study and assigned to study treatment.

Analyses of primary/ secondary outcome measures were planned and performed in different analysis populations described in respective analysis population descriptions. Analyses of few secondary outcome measures and adverse events were planned and performed according to predefined subgroup populations and have been presented accordingly.

Participant milestones

Participant milestones
Measure	TCZ - All Participants Participants in core study period received tocilizumab (TCZ, RoActemra) at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week as monotherapy or in combination with Methotrexate (MTX) or other Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) (at investigator's discretion) for 24 weeks. Participants who completed the core study period were allowed to enter a Long-term-extension (LTE) period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC TCZ, whichever came first.
Core Study Period (24 Weeks) STARTED	139
Core Study Period (24 Weeks) COMPLETED	116
Core Study Period (24 Weeks) NOT COMPLETED	23
LTE Period (52 Weeks) STARTED	116
LTE Period (52 Weeks) COMPLETED	107
LTE Period (52 Weeks) NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	TCZ - All Participants Participants in core study period received tocilizumab (TCZ, RoActemra) at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week as monotherapy or in combination with Methotrexate (MTX) or other Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) (at investigator's discretion) for 24 weeks. Participants who completed the core study period were allowed to enter a Long-term-extension (LTE) period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC TCZ, whichever came first.
Core Study Period (24 Weeks) Adverse Event	9
Core Study Period (24 Weeks) Death	1
Core Study Period (24 Weeks) Non-Serious Hypersensitivity Reaction	2
Core Study Period (24 Weeks) Physician Decision	1
Core Study Period (24 Weeks) Withdrawal by Subject	4
Core Study Period (24 Weeks) Protocol Violation	3
Core Study Period (24 Weeks) Lack of Efficacy	3
LTE Period (52 Weeks) Lost to Follow-up	2
LTE Period (52 Weeks) Physician Decision	2
LTE Period (52 Weeks) Withdrawal by Subject	1
LTE Period (52 Weeks) Lack of Efficacy	1
LTE Period (52 Weeks) Other	3

Baseline Characteristics

A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TCZ - All Participants n=139 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks. Participants who completed the core study period were allowed to enter a LTE period to continue study treatment for up to a maximum of another 52 weeks or until the commercial availability of SC TCZ, whichever came first.
Age, Continuous	57.3 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure. In case of missing value, Last Observation Carried Forward (LOCF) method was applied.

The DAS28-ESR was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and Patient Global Assessment of disease activity (PGA) according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=136 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Disease Activity Score Based on 28-joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24 Baseline	5.80 units on a scale Standard Deviation 1.14	—
Change From Baseline in Disease Activity Score Based on 28-joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24 Change at Week 24	-3.07 units on a scale Standard Deviation 1.52	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.

The DAS28-ESR was derived from assessments of ESR, TJC, SJC, and PGA according to 100-mm VAS. DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=42 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=94 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in DAS28-ESR at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 2	-1.19 units on a scale Standard Deviation 1.05	-1.41 units on a scale Standard Deviation 1.03
Change From Baseline in DAS28-ESR at Weeks 2, 4, 8, 12, 16, 20, and 24 Baseline	6.08 units on a scale Standard Deviation 1.21	5.67 units on a scale Standard Deviation 1.10
Change From Baseline in DAS28-ESR at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 4	-2.16 units on a scale Standard Deviation 1.17	-2.21 units on a scale Standard Deviation 1.14
Change From Baseline in DAS28-ESR at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 8	-2.70 units on a scale Standard Deviation 1.40	-2.74 units on a scale Standard Deviation 1.36
Change From Baseline in DAS28-ESR at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 12	-3.16 units on a scale Standard Deviation 1.54	-3.02 units on a scale Standard Deviation 1.33
Change From Baseline in DAS28-ESR at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 16	-3.20 units on a scale Standard Deviation 1.59	-3.08 units on a scale Standard Deviation 1.29
Change From Baseline in DAS28-ESR at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 20	-3.27 units on a scale Standard Deviation 1.35	-3.21 units on a scale Standard Deviation 1.43
Change From Baseline in DAS28-ESR at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 24	-3.01 units on a scale Standard Deviation 1.62	-3.10 units on a scale Standard Deviation 1.48

SECONDARY outcome

Timeframe: Week 24

Population: FAS; In case of missing value at Week 24, LOCF method was applied.

The DAS28-ESR was derived from assessments of ESR, TJC, SJC, and PGA according to 100-mm VAS. DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. DAS28-ESR score less than or equal to (\</=) 3.2 indicates LDA, DAS28-ESR score greater than (\>) 3.2 indicates moderate to high disease activity, and DAS28-ESR less than (\<) 2.6 indicates remission. Percentage of participants with DAS28-ESR LDA and remission at Week 24 is reported. 95 percent (%) confidence interval (CI) was determined using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=43 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=96 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With DAS28-ESR Low Disease Activity (LDA) and Remission at Week 24 LDA	67.4 percentage of participants Interval 51.46 to 80.92	70.8 percentage of participants Interval 60.67 to 79.67
Percentage of Participants With DAS28-ESR Low Disease Activity (LDA) and Remission at Week 24 Remission	41.9 percentage of participants Interval 27.01 to 57.87	55.2 percentage of participants Interval 44.71 to 65.37

SECONDARY outcome

Timeframe: Baseline, Week 24, last assessment (up to Week 76)

Population: LTE population included all FAS participants who received at least one dose of SC TCZ after Week 24 visit. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. In case of missing value at Week 24, LOCF method was applied.

The DAS28-ESR was derived from assessments of ESR, TJC, SJC, and PGA according to 100-millimeter (mm) VAS. DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=63 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in DAS28-ESR at Week 24 and at Last Assessment Baseline	5.90 units on a scale Standard Deviation 1.26	—
Change From Baseline in DAS28-ESR at Week 24 and at Last Assessment Change at Week 24	-3.30 units on a scale Standard Deviation 1.44	—
Change From Baseline in DAS28-ESR at Week 24 and at Last Assessment Change at Last Assessment	-3.41 units on a scale Standard Deviation 1.47	—

SECONDARY outcome

Timeframe: Week 24, last assessment (up to Week 76)

Population: LTE population; In case of missing value at Week 24, LOCF method was applied.

The DAS28-ESR was derived from assessments of ESR, TJC, SJC, and PGA according to 100-mm VAS. DAS28-ESR scores were calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. DAS28-ESR score \</=3.2 indicates LDA, DAS28-ESR score \>3.2 indicates moderate to high disease activity, and DAS28-ESR \<2.6 indicates remission. Percentage of participants with DAS28-ESR LDA and remission at Week 24 and at last assessment is reported.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=64 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With DAS28-ESR LDA and Remission at Week 24 and at Last Assessment Week 24, LDA	71.9 percentage of participants	—
Percentage of Participants With DAS28-ESR LDA and Remission at Week 24 and at Last Assessment Week 24, Remission	54.7 percentage of participants	—
Percentage of Participants With DAS28-ESR LDA and Remission at Week 24 and at Last Assessment Last Assessment, LDA	71.9 percentage of participants	—
Percentage of Participants With DAS28-ESR LDA and Remission at Week 24 and at Last Assessment Last Assessment, Remission	53.1 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure. Missing data was considered as non-response.

The ACR 20, 50, and 70 responses at any time was defined as greater than or equal to (\>/=) 20%, 50%, and 70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20%, 50%, 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) PGA according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via a Health Assessment Questionnaire-Disability Index (HAQ-DI), and 5) Acute phase reactant (ESR in mm/h or C-Reactive Protein \[CRP\] in milligrams per liter \[mg/L\]). Percentage of participants with ACR 20, 50, and 70 responses at Week 24 is reported. 95% CI was determined using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=33 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=84 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response at Week 24 ACR20	69.7 percentage of participants Interval 51.29 to 84.41	73.8 percentage of participants Interval 63.07 to 82.8
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response at Week 24 ACR50	54.5 percentage of participants Interval 36.35 to 71.89	52.4 percentage of participants Interval 41.19 to 63.4
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response at Week 24 ACR70	33.3 percentage of participants Interval 17.96 to 51.83	28.6 percentage of participants Interval 19.24 to 39.47

SECONDARY outcome

Timeframe: Baseline, Week 24, last assessment (up to Week 76)

Population: LTE population; Missing data was considered as non-response.

The ACR 20, 50, and 70 responses at any time is defined as \>/=20%, 50%, and 70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20%, 50%, 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) PGA according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/L). Percentage of participants with ACR 20, 50, and 70 responses at Week 24 and at last assessment is reported.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=64 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants Achieving ACR20, ACR50, and ACR70 Response at Week 24 and at Last Assessment Week 24, ACR20	76.6 percentage of participants	—
Percentage of Participants Achieving ACR20, ACR50, and ACR70 Response at Week 24 and at Last Assessment Week 24, ACR50	51.6 percentage of participants	—
Percentage of Participants Achieving ACR20, ACR50, and ACR70 Response at Week 24 and at Last Assessment Week 24, ACR70	35.9 percentage of participants	—
Percentage of Participants Achieving ACR20, ACR50, and ACR70 Response at Week 24 and at Last Assessment Last Assessment, ACR20	76.6 percentage of participants	—
Percentage of Participants Achieving ACR20, ACR50, and ACR70 Response at Week 24 and at Last Assessment Last Assessment, ACR50	56.3 percentage of participants	—
Percentage of Participants Achieving ACR20, ACR50, and ACR70 Response at Week 24 and at Last Assessment Last Assessment, ACR70	37.5 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: FAS; Missing data was considered as non-response.

The DAS28-ESR-based EULAR response criteria were used to measure individual response as 'Good', 'Moderate', and 'No Response', depending upon DAS28-ESR absolute scores at Week 24 and the DAS28-ESR reduction from Baseline to Week 24. Good Response: change from baseline \>1.2 with DAS28-ESR score \</=3.2; Moderate Response: change from baseline \>1.2 with DAS28-ESR score \>3.2 to \</=5.1 or change from baseline \>0.6 to \</=1.2 with DAS28-ESR score \</=5.1; No Response: change from baseline \</=0.6 or change from baseline \>0.6 and \</=1.2 with DAS28-ESR score \>5.1. Percentage of participants with EULAR responses at Week 24 is reported. 95% CI was determined using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=43 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=96 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-ESR at Week 24 Good Response	58.1 percentage of participants Interval 42.13 to 72.99	60.4 percentage of participants Interval 49.92 to 70.25
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-ESR at Week 24 Moderate Response	14.0 percentage of participants Interval 5.3 to 27.93	19.8 percentage of participants Interval 12.36 to 29.17
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-ESR at Week 24 No Response	27.9 percentage of participants Interval 15.33 to 43.67	19.8 percentage of participants Interval 12.36 to 29.17

SECONDARY outcome

Timeframe: Baseline, Week 24, last assessment (up to Week 76)

Population: LTE population; Missing data was considered as non-response.

The DAS28-ESR-based EULAR response criteria were used to measure individual response as 'Good', 'Moderate', and 'No Response', depending upon DAS28-ESR absolute scores at Week 24 and the DAS28-ESR reduction from Baseline to Week 24. Good Response: change from baseline \>1.2 with DAS28-ESR score \</=3.2; Moderate Response: change from baseline \>1.2 with DAS28-ESR score \>3.2 to \</=5.1 or change from baseline \>0.6 to \</=1.2 with DAS28-ESR score \</=5.1; No Response: change from baseline \</=0.6 or change from baseline \>0.6 and \</=1.2 with DAS28-ESR score \>5.1. Percentage of participants with EULAR responses at Week 24 and at last assessment is reported.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=64 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With EULAR Response Based on DAS28-ESR at Week 24 and at Last Assessment Week 24, Good Response	68.8 percentage of participants	—
Percentage of Participants With EULAR Response Based on DAS28-ESR at Week 24 and at Last Assessment Week 24, Moderate Response	26.6 percentage of participants	—
Percentage of Participants With EULAR Response Based on DAS28-ESR at Week 24 and at Last Assessment Week 24, No Response	4.7 percentage of participants	—
Percentage of Participants With EULAR Response Based on DAS28-ESR at Week 24 and at Last Assessment Last Assessment, Good Response	65.6 percentage of participants	—
Percentage of Participants With EULAR Response Based on DAS28-ESR at Week 24 and at Last Assessment Last Assessment, Moderate Response	31.3 percentage of participants	—
Percentage of Participants With EULAR Response Based on DAS28-ESR at Week 24 and at Last Assessment Last Assessment, No Response	3.1 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.

SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS and CRP in mg per deciliter (dL). Higher scores indicate greater affection due to disease activity. SDAI total score = 0-86. SDAI \</=3.3 indicates disease remission, \</=11 indicates LDA, \</=26 indicates moderate disease activity, and \>26 indicates high disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=39 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=90 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Baseline	35.42 units on a scale Standard Deviation 12.61	31.47 units on a scale Standard Deviation 11.77
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 2	-8.54 units on a scale Standard Deviation 10.67	-9.20 units on a scale Standard Deviation 9.37
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 4	-14.23 units on a scale Standard Deviation 10.76	-14.62 units on a scale Standard Deviation 11.33
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 8	-20.20 units on a scale Standard Deviation 13.22	-17.47 units on a scale Standard Deviation 12.47
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 12	-23.09 units on a scale Standard Deviation 13.82	-20.33 units on a scale Standard Deviation 12.97
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 16	-24.31 units on a scale Standard Deviation 15.14	-21.39 units on a scale Standard Deviation 12.66
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 20	-24.41 units on a scale Standard Deviation 15.28	-21.93 units on a scale Standard Deviation 13.35
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 24	-22.45 units on a scale Standard Deviation 14.48	-20.31 units on a scale Standard Deviation 13.34

SECONDARY outcome

Timeframe: Week 24

Population: FAS; Missing data was considered as non-response.

SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS and CRP in mg/dL. Higher scores indicate greater affection due to disease activity. SDAI total score = 0-86. SDAI \</=3.3 indicates disease remission, \</=11 indicates LDA, \</=26 indicates moderate disease activity, and \>26 indicates high disease activity. Percentage of participants with SDAI LDA and remission at Week 24 is reported. 95% CI was determined using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=43 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=96 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With SDAI LDA and Remission at Week 24 LDA	46.5 percentage of participants Interval 31.18 to 62.35	59.4 percentage of participants Interval 48.87 to 69.29
Percentage of Participants With SDAI LDA and Remission at Week 24 Remission	18.6 percentage of participants Interval 8.39 to 33.4	19.8 percentage of participants Interval 12.36 to 29.17

SECONDARY outcome

Timeframe: Baseline, Week 24, last assessment (up to Week 76)

Population: LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points. In case of missing value at Week 24, LOCF method was applied.

SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS and CRP in mg/dL. Higher scores indicate greater affection due to disease activity. SDAI total score = 0-86. SDAI \</=3.3 indicates disease remission, \</=11 indicates LDA, \</=26 indicates moderate disease activity, and \>26 indicates high disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=57 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in SDAI at Week 24 and at Last Assessment Change at Week 24	-23.29 units on a scale Standard Deviation 13.81	—
Change From Baseline in SDAI at Week 24 and at Last Assessment Change at Last Assessment	-24.36 units on a scale Standard Deviation 12.61	—

SECONDARY outcome

Timeframe: Week 24, last assessment (up to Week 76)

Population: LTE population; Missing data was considered as non-response.

SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS and CRP in mg/dL. Higher scores indicate greater affection due to disease activity. SDAI total score = 0-86. SDAI \</=3.3 indicates disease remission, \</=11 indicates LDA, \</=26 indicates moderate disease activity, and \>26 indicates high disease activity. Percentage of participants with SDAI LDA and remission at Week 24 and at last assessment is reported.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=64 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With SDAI LDA and Remission at Week 24 and at Last Assessment Week 24, LDA	57.8 percentage of participants	—
Percentage of Participants With SDAI LDA and Remission at Week 24 and at Last Assessment Week 24, Remission	20.3 percentage of participants	—
Percentage of Participants With SDAI LDA and Remission at Week 24 and at Last Assessment Last Assessment, LDA	64.1 percentage of participants	—
Percentage of Participants With SDAI LDA and Remission at Week 24 and at Last Assessment Last Assessment, Remission	25.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.

CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score \</=2.8 indicates disease remission, \</=10 indicates LDA, \</=22 indicates moderate disease activity, and \>22 indicates high disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=39 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=90 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Baseline	32.17 units on a scale Standard Deviation 11.11	29.34 units on a scale Standard Deviation 11.05
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 2	-5.57 units on a scale Standard Deviation 9.69	-7.15 units on a scale Standard Deviation 8.87
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 4	-11.17 units on a scale Standard Deviation 10.14	-12.65 units on a scale Standard Deviation 10.97
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 8	-17.32 units on a scale Standard Deviation 12.00	-15.75 units on a scale Standard Deviation 11.62
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 12	-20.25 units on a scale Standard Deviation 12.50	-18.17 units on a scale Standard Deviation 12.20
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 16	-20.24 units on a scale Standard Deviation 14.13	-19.25 units on a scale Standard Deviation 11.88
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 20	-21.27 units on a scale Standard Deviation 13.58	-19.29 units on a scale Standard Deviation 12.82
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 24	-19.45 units on a scale Standard Deviation 13.34	-18.40 units on a scale Standard Deviation 12.78

SECONDARY outcome

Timeframe: Week 24

Population: FAS; Missing data was considered as non-response.

CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score \</=2.8 indicates disease remission, \</=10 indicates LDA, \</=22 indicates moderate disease activity, and \>22 indicates high disease activity. Percentage of participants with CDAI LDA and remission at Week 24 is reported. 95% CI was determined using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=43 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=96 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With CDAI LDA and Remission at Week 24 LDA	44.2 percentage of participants Interval 29.08 to 60.12	60.4 percentage of participants Interval 49.92 to 70.25
Percentage of Participants With CDAI LDA and Remission at Week 24 Remission	16.3 percentage of participants Interval 6.81 to 30.7	16.7 percentage of participants Interval 9.84 to 25.65

SECONDARY outcome

Timeframe: Baseline, Week 24, last assessment (up to Week 76)

Population: LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points. In case of missing value at Week 24, LOCF method was applied.

CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score \</=2.8 indicates disease remission, \</=10 indicates LDA, \</=22 indicates moderate disease activity, and \>22 indicates high disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=57 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in CDAI at Week 24 and at Last Assessment Change at Week 24	-20.85 units on a scale Standard Deviation 13.06	—
Change From Baseline in CDAI at Week 24 and at Last Assessment Change at Last Assessment	-21.74 units on a scale Standard Deviation 12.06	—

SECONDARY outcome

Timeframe: Week 24, last assessment (up to Week 76)

Population: LTE population; Missing data was considered as non-response.

CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score \</=2.8 indicates disease remission, \</=10 indicates LDA, \</=22 indicates moderate disease activity, and \>22 indicates high disease activity. Percentage of participants with CDAI LDA and remission at Week 24 and at last assessment is reported.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=64 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With CDAI LDA and Remission at Week 24 and at Last Assessment Week 24, LDA	57.8 percentage of participants	—
Percentage of Participants With CDAI LDA and Remission at Week 24 and at Last Assessment Week 24, Remission	17.2 percentage of participants	—
Percentage of Participants With CDAI LDA and Remission at Week 24 and at Last Assessment Last Assessment, LDA	60.9 percentage of participants	—
Percentage of Participants With CDAI LDA and Remission at Week 24 and at Last Assessment Last Assessment, Remission	23.4 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24

Population: FAS; Here, 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.

A total of 28 joints were assessed for swelling. The number of swollen joints at could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=43 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=96 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in SJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Baseline	6.0 swollen joints Interval 0.0 to 24.0	7.0 swollen joints Interval 0.0 to 23.0
Change From Baseline in SJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 2	-1.0 swollen joints Interval -9.0 to 14.0	-2.0 swollen joints Interval -13.0 to 8.0
Change From Baseline in SJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 4	-3.0 swollen joints Interval -8.0 to 4.0	-3.0 swollen joints Interval -18.0 to 5.0
Change From Baseline in SJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 8	-3.5 swollen joints Interval -18.0 to 6.0	-4.0 swollen joints Interval -17.0 to 3.0
Change From Baseline in SJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 12	-4.0 swollen joints Interval -22.0 to 3.0	-5.0 swollen joints Interval -23.0 to 2.0
Change From Baseline in SJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 16	-5.0 swollen joints Interval -22.0 to 6.0	-5.0 swollen joints Interval -23.0 to 2.0
Change From Baseline in SJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 20	-4.0 swollen joints Interval -21.0 to 3.0	-5.0 swollen joints Interval -22.0 to 4.0
Change From Baseline in SJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 24	-5.0 swollen joints Interval -21.0 to 14.0	-5.0 swollen joints Interval -23.0 to 2.0

SECONDARY outcome

Timeframe: Baseline, Week 24, last assessment (up to Week 76)

Population: LTE population; In case of missing value at Week 24, LOCF method was applied.

A total of 28 joints were assessed for swelling. The number of swollen joints at could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=64 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in SJC at Week 24 and at Last Assessment Change at Week 24	-6.0 swollen joints Interval -23.0 to 2.0	—
Change From Baseline in SJC at Week 24 and at Last Assessment Change at Last Assessment	-6.5 swollen joints Interval -22.0 to 5.0	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24

Population: FAS; Here, 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.

A total of 28 joints were assessed for tenderness. The number of tender joints at could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=43 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=96 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in TJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Baseline	12.0 tender joints Interval 0.0 to 28.0	8.0 tender joints Interval 0.0 to 27.0
Change From Baseline in TJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 2	-1.0 tender joints Interval -13.0 to 12.0	-2.0 tender joints Interval -18.0 to 12.0
Change From Baseline in TJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 4	-2.5 tender joints Interval -17.0 to 4.0	-3.0 tender joints Interval -20.0 to 10.0
Change From Baseline in TJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 8	-6.5 tender joints Interval -19.0 to 12.0	-5.0 tender joints Interval -21.0 to 8.0
Change From Baseline in TJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 12	-8.0 tender joints Interval -23.0 to 3.0	-5.0 tender joints Interval -20.0 to 17.0
Change From Baseline in TJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 16	-8.0 tender joints Interval -24.0 to 8.0	-5.5 tender joints Interval -23.0 to 4.0
Change From Baseline in TJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 20	-8.0 tender joints Interval -27.0 to 5.0	-5.0 tender joints Interval -25.0 to 12.0
Change From Baseline in TJC at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 24	-8.0 tender joints Interval -27.0 to 12.0	-5.0 tender joints Interval -27.0 to 15.0

SECONDARY outcome

Timeframe: Baseline, Week 24, last assessment (up to Week 76)

Population: LTE population; In case of missing value at Week 24, LOCF method was applied.

A total of 28 joints were assessed for tenderness. The number of tender joints at could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=64 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in TJC at Week 24 and at Last Assessment Change at Week 24	-6.5 tender joints Interval -27.0 to 15.0	—
Change From Baseline in TJC at Week 24 and at Last Assessment Change at Last Assessment	-6.0 tender joints Interval -27.0 to 9.0	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points. In case of missing value at Week 24, LOCF method was applied.

Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity (0 mm=none; 100 mm=very severe). The change from Baseline to any time point was averaged among all participants, where negative change indicated a decrease in physician-assessed disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=132 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, 8, 12, 16, 20, and 24 Baseline	62.08 mm Standard Deviation 17.68	—
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 2	-11.38 mm Standard Deviation 15.91	—
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 4	-22.10 mm Standard Deviation 20.25	—
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 8	-29.67 mm Standard Deviation 23.33	—
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 12	-35.25 mm Standard Deviation 22.03	—
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 16	-35.69 mm Standard Deviation 23.33	—
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 20	-37.80 mm Standard Deviation 21.80	—
Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, 8, 12, 16, 20, and 24 Change at Week 24	-34.98 mm Standard Deviation 22.43	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

Population: Quality of Life (QoL) population included all enrolled participants with at least one electronic patient-reported outcome (ePRO) questionnaire completed. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure and 'Number Analyzed' = number of participants evaluable at specified time points.

Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity (0 mm=none; 100 mm=very severe). The change from Baseline to any time point was averaged among all participants, where negative change indicated a decrease in participant-assessed disease activity.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=136 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Baseline	59.88 mm Standard Deviation 24.14	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 2	-8.11 mm Standard Deviation 21.64	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 4	-17.19 mm Standard Deviation 25.71	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 8	-24.49 mm Standard Deviation 29.94	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 12	-29.62 mm Standard Deviation 29.84	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 16	-31.61 mm Standard Deviation 28.89	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 20	-31.80 mm Standard Deviation 31.16	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 24	-33.79 mm Standard Deviation 31.19	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 28	-37.90 mm Standard Deviation 29.87	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 32	-33.96 mm Standard Deviation 32.19	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 36	-34.10 mm Standard Deviation 30.05	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 40	-37.74 mm Standard Deviation 28.63	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 44	-36.55 mm Standard Deviation 26.27	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 48	-37.63 mm Standard Deviation 26.07	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 52	-37.50 mm Standard Deviation 33.25	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 56	-41.00 mm Standard Deviation 41.91	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 60	-46.00 mm Standard Deviation 49.50	—
Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 64	-42.50 mm Standard Deviation 53.03	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

Participant-assessed pain was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of pain (0 mm=none; 100 mm=very severe). The change from Baseline to any time point was averaged among all participants, where negative change indicated a decrease in participant-assessed pain.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=135 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Baseline	57.57 mm Standard Deviation 26.78	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 2	-7.50 mm Standard Deviation 22.78	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 4	-15.28 mm Standard Deviation 29.76	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 8	-22.58 mm Standard Deviation 32.15	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 12	-28.29 mm Standard Deviation 32.04	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 16	-29.50 mm Standard Deviation 29.98	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 20	-30.55 mm Standard Deviation 29.98	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 24	-31.85 mm Standard Deviation 30.21	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 28	-33.29 mm Standard Deviation 31.84	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 32	-32.67 mm Standard Deviation 30.98	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 36	-34.51 mm Standard Deviation 30.03	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 40	-34.36 mm Standard Deviation 31.07	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 44	-32.30 mm Standard Deviation 27.10	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 48	-35.56 mm Standard Deviation 26.27	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 52	-36.42 mm Standard Deviation 32.77	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 56	-39.50 mm Standard Deviation 34.67	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 60	-42.00 mm Standard Deviation 43.84	—
Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 64	-40.00 mm Standard Deviation 43.84	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated questions), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). The changes from Baseline to any time point were averaged among all participants, where negative changes indicated an increase in fatigue.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=134 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Baseline	25.44 units on a scale Standard Deviation 11.97	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 2	3.71 units on a scale Standard Deviation 8.20	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 4	6.08 units on a scale Standard Deviation 9.74	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 8	7.98 units on a scale Standard Deviation 12.36	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 12	9.43 units on a scale Standard Deviation 11.54	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 16	9.19 units on a scale Standard Deviation 11.89	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 20	8.84 units on a scale Standard Deviation 12.68	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 24	9.26 units on a scale Standard Deviation 13.08	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 28	11.54 units on a scale Standard Deviation 12.18	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 32	9.87 units on a scale Standard Deviation 12.25	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 36	8.63 units on a scale Standard Deviation 12.17	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 40	10.41 units on a scale Standard Deviation 11.73	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 44	10.30 units on a scale Standard Deviation 12.37	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 48	11.50 units on a scale Standard Deviation 9.14	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 52	12.25 units on a scale Standard Deviation 10.70	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 56	14.83 units on a scale Standard Deviation 7.36	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 60	17.00 units on a scale Standard Deviation 7.07	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Change at Week 64	20.00 units on a scale Standard Deviation 7.07	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

HAQ-DI assessed 20 items in 8 functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score (range = 0-3) was calculated as an average of all item scores. Percentage of participants with HAQ-DI remission (HAQ-DI score \<0.5) at each time point is reported.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=134 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Baseline	6.0 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 2	8.4 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 4	12.6 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 8	23.3 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 12	31.7 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 16	35.9 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 20	31.3 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 24	30.3 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 28	37.3 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 32	32.1 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 36	25.0 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 40	30.4 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 44	30.0 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 48	25.0 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 52	33.3 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 56	33.3 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 60	50.0 percentage of participants	—
Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 64	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

HAQ-DI assessed 20 items in 8 functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score (range = 0-3) was calculated as an average of all item scores. Percentage of participants with HAQ-DI clinically meaningful improvement (reduction in HAQ-DI score from baseline \>/=0.22) at each time point is reported.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=134 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 2	42.5 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 4	55.3 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 8	62.1 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 12	71.6 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 16	75.0 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 20	67.6 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 24	73.6 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 28	76.8 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 32	72.0 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 36	64.9 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 40	73.9 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 44	65.0 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 48	62.5 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 52	50.0 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 56	66.7 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 60	100.0 percentage of participants	—
Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 Week 64	50.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Treatment compliance from Baseline up to Week 24 was assessed using following formula: (number of actual injection received / number of theoretical injection which should be received at week 24) \* 100.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=135 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Treatment Compliance From Baseline up to Week 24	91.19 percentage of injections Standard Deviation 15.54	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 28, 40, 52, and 64

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

RAID assessed the impact of rheumatoid arthritis on participant's quality of life. It comprised 7 domains: pain, function, fatigue, physical and psychological well-being, sleep disturbance and coping. Each domain was a single question scored from 0 (best) to 10 (worst) on a continuous numerical rating scale (NRS). Each domain also had a specific weight assigned by a participant survey and RAID total score ranged from 0 (best) to 10 (worst). If only 1 domain was missing it was replaced by the mean of the others; otherwise, RAID score was not calculated. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better quality of life.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=133 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score at Weeks 12, 24, 28, 40, 52, and 64 Baseline	5.94 units on a scale Standard Deviation 2.27	—
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 12	-2.74 units on a scale Standard Deviation 2.39	—
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 24	-2.94 units on a scale Standard Deviation 2.65	—
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 28	-2.99 units on a scale Standard Deviation 2.50	—
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 40	-3.21 units on a scale Standard Deviation 2.46	—
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 52	-3.27 units on a scale Standard Deviation 2.52	—
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 64	-5.59 units on a scale Standard Deviation 0.74	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 12, 24, 28, 40, 52, and 64

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

RAPID-3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain VAS, and PGA VAS. The total RAPID-3 score ranges from 0 to 10 where higher scores represent worse outcomes. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=134 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64 Baseline	15.41 units on a scale Standard Deviation 6.54	—
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64 Change at Week 2	-1.72 units on a scale Standard Deviation 4.96	—
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64 Change at Week 4	-4.18 units on a scale Standard Deviation 6.08	—
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64 Change at Week 12	-7.07 units on a scale Standard Deviation 7.01	—
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64 Change at Week 24	-7.68 units on a scale Standard Deviation 7.16	—
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64 Change at Week 28	-8.16 units on a scale Standard Deviation 6.81	—
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64 Change at Week 40	-8.86 units on a scale Standard Deviation 6.70	—
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64 Change at Week 52	-8.91 units on a scale Standard Deviation 7.79	—
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64 Change at Week 64	-9.00 units on a scale Standard Deviation 9.90	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 52, and last assessment (up to Week 76)

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

Participants were asked: "If you were to remain in the same condition for the next few months as you have been over the last 8 days, would this be 1) acceptable, 2) Inacceptable?" The number of participants who responded "acceptable" or "Inacceptable" at each time point is presented.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=132 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Number of Participants With Patient Acceptable Symptom State (PASS) Score Baseline, Acceptable	31 Participants	—
Number of Participants With Patient Acceptable Symptom State (PASS) Score Baseline, Inacceptable	101 Participants	—
Number of Participants With Patient Acceptable Symptom State (PASS) Score Week 24, Acceptable	78 Participants	—
Number of Participants With Patient Acceptable Symptom State (PASS) Score Week 24, Incceptable	27 Participants	—
Number of Participants With Patient Acceptable Symptom State (PASS) Score Week 52, Acceptable	8 Participants	—
Number of Participants With Patient Acceptable Symptom State (PASS) Score Week 52, Inacceptable	3 Participants	—
Number of Participants With Patient Acceptable Symptom State (PASS) Score Last Assessment, Acceptable	83 Participants	—
Number of Participants With Patient Acceptable Symptom State (PASS) Score Last Assessment, Inacceptable	35 Participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

BRAF-MDQ assessed the overall experience and impact of disease related fatigue, using four dimensions (physical fatigue \[4 items\], living with fatigue \[7 items\], cognitive fatigue \[5 items\], and emotional fatigue \[4 items\]). A total fatigue score (range 0 to 70) was obtained by summing the 20 item scores ranging from 0 to 3, except for item 1 (0-10), item 2 (0-7) and item 3 (0-2). Higher scores reflect greater fatigue. If only 1 domain was missing it was replaced by the mean of the others; otherwise, the total score was not calculated. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better quality of life.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=129 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ) Total Score at Weeks 24 and 52 Baseline	35.50 units on a scale Standard Deviation 18.93	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ) Total Score at Weeks 24 and 52 Change at Week 24	-13.18 units on a scale Standard Deviation 18.56	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ) Total Score at Weeks 24 and 52 Change at Week 52	-20.09 units on a scale Standard Deviation 19.02	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 52

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

BRAF-NRS are 3 standardized NRS (range = 0-10) for disease related fatigue domains (severity of fatigue, fatigue effect, and coping with fatigue). Higher values reflect greater problems for severity/level fatigue and effect fatigue NRS, but lower scores reflect greater problems for copped fatigue NRS.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=133 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52 Baseline, Level Fatigue NRS	6.14 units on a scale Standard Deviation 2.56	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52 Baseline, Effect Fatigue NRS	5.87 units on a scale Standard Deviation 2.75	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52 Baseline, Copped Fatigue NRS	5.48 units on a scale Standard Deviation 2.52	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52 Change at Week 24, Level Fatigue NRS	-2.41 units on a scale Standard Deviation 2.90	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52 Change at Week 24, Effect Fatigue NRS	-2.44 units on a scale Standard Deviation 2.90	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52 Change at Week 24, Copped Fatigue NRS	-0.47 units on a scale Standard Deviation 3.91	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52 Change at Week 52, Level Fatigue NRS	-3.75 units on a scale Standard Deviation 2.93	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52 Change at Week 52, Effect Fatigue NRS	-3.83 units on a scale Standard Deviation 2.86	—
Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52 Change at Week 52, Copped Fatigue NRS	-1.33 units on a scale Standard Deviation 2.84	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 28, 40, 52, and 64

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

MOS sleep scale comprised of 6-item with each item score ranged from 0 to 100. The total score was the average of scores sum (range 0-100), with highest values reflecting biggest participant's sleeping problems. If more than 3 items were missing the index was not calculated. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=133 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Medical Outcome Study (MOS) Sleep Questionnaire Score at Weeks 12, 24, 28, 40, 52, and 64 Baseline	47.09 units on a scale Standard Deviation 21.66	—
Change From Baseline in Medical Outcome Study (MOS) Sleep Questionnaire Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 12	-7.21 units on a scale Standard Deviation 18.85	—
Change From Baseline in Medical Outcome Study (MOS) Sleep Questionnaire Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 24	-5.44 units on a scale Standard Deviation 19.83	—
Change From Baseline in Medical Outcome Study (MOS) Sleep Questionnaire Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 28	-8.48 units on a scale Standard Deviation 15.04	—
Change From Baseline in Medical Outcome Study (MOS) Sleep Questionnaire Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 40	-5.56 units on a scale Standard Deviation 14.45	—
Change From Baseline in Medical Outcome Study (MOS) Sleep Questionnaire Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 52	-8.33 units on a scale Standard Deviation 18.11	—
Change From Baseline in Medical Outcome Study (MOS) Sleep Questionnaire Score at Weeks 12, 24, 28, 40, 52, and 64 Change at Week 64	-27.08 units on a scale Standard Deviation 2.95	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64

Population: QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.

FLARE is a 13-item questionnaire assessed disease flares between two medical consultations. Each item score ranged from 0 (completely untrue) to 10 (absolutely true) on a 6-step scale. The FLARE questionnaire global score (range = 0-10) is a mean score of 11 of the 13 items \[items 6 ('doses of pain killers or anti-inflammatory medication') and 13 ('need for help') not taken into account\], with the highest score corresponding to the highest disease activity. The global score was computed if at least the scores of 6 items were available. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=134 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Baseline	5.61 units on a scale Standard Deviation 2.77	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 2	-1.35 units on a scale Standard Deviation 2.41	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 4	-2.38 units on a scale Standard Deviation 2.64	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 8	-2.94 units on a scale Standard Deviation 3.18	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 12	-3.41 units on a scale Standard Deviation 2.62	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 16	-3.10 units on a scale Standard Deviation 2.89	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 20	-3.30 units on a scale Standard Deviation 2.93	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 24	-3.41 units on a scale Standard Deviation 2.75	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 28	-3.31 units on a scale Standard Deviation 2.54	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 40	-3.44 units on a scale Standard Deviation 2.01	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 52	-4.16 units on a scale Standard Deviation 1.99	—
Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64 Change at Week 64	-7.55 units on a scale Standard Deviation 1.54	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: QoL population was planned to be included in the analysis. Data for this outcome measure could not be analyzed due to unavailability of the methodology to calculate the BioSecure global score and sub-scores.

The BioSecure questionnaire comprised of 54-item aimed at evaluating the safety competences of participants (for example, participants' self-care safety skills and socio-demographic characteristics, type of information received, quality of life, and coping style data) treated by biologics for inflammatory arthritis and to determine the factors associated with a lower level of competences.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Percentage of participants with a discontinuation in corticosteroid dosage during core study period is reported. The discontinuations were categorized as either permanent or temporary. Participants with temporary discontinuation first followed by permanent discontinuation were counted in both categories. Participants who were receiving corticosteroids at Baseline were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=24 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=55 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With Discontinuations of Corticosteroid Dosage During Core Study Period Permanent Discontinuation	8.3 percentage of participants	7.3 percentage of participants
Percentage of Participants With Discontinuations of Corticosteroid Dosage During Core Study Period Temporary Discontinuation	16.7 percentage of participants	7.3 percentage of participants

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Time to permanent discontinuation in corticosteroid dosage during core study period is reported. Participants who permanently discontinued corticosteroids at any time during core study period were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=2 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=4 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Time to Permanent Discontinuation of Corticosteroid Dosage During Core Study Period	24 days Interval 1.0 to 46.0	96 days Interval 24.0 to 114.0

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Time to first temporary discontinuation in corticosteroid dosage during core study period is reported. Participants who temporarily discontinued corticosteroids at any time during core study period were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=4 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=4 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Time to First Temporary Discontinuation of Corticosteroid Dosage During Core Study Period	50 days Interval 1.0 to 156.0	105 days Interval 76.0 to 138.0

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)

Population: FAS

Percentage of participants with a change in corticosteroid dosage during core study period compared to Baseline is reported. The change included either an initiation/ increase (\>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (\</=-5mg/day prednisone or equivalent) of corticosteroid dosage.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=43 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=96 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With Change in Corticosteroid Dosage During Core Study Period Initiation/ Increase	0.0 percentage of participants	3.1 percentage of participants
Percentage of Participants With Change in Corticosteroid Dosage During Core Study Period Decrease	14.0 percentage of participants	9.4 percentage of participants

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories for different arms, respectively.

Time to first change in corticosteroid dosage during core study period compared to Baseline is reported. The change included either an initiation/ increase (\>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (\</=-5mg/day prednisone or equivalent) of corticosteroid dosage. Participants with a change in corticosteroid dosage during core study period were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=6 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=12 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Time to Change in Corticosteroid Dosage During Core Study Period Initiation/ Increase	—	38 days Interval 23.0 to 50.0
Time to Change in Corticosteroid Dosage During Core Study Period Decrease	98 days Interval 1.0 to 239.0	107 days Interval 25.0 to 225.0

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories for different arms, respectively.

Number of participants according to reasons for a change in corticosteroid dosage during core study period compared to Baseline is reported. The change included either an initiation/ increase (\>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (\</=-5mg/day prednisone or equivalent) of corticosteroid dosage. Participants with a change in corticosteroid dosage during core study period were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=6 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period n=12 Participants Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Core Study Period Initiation/ Increase, Lack of Efficacy	0 Participants	1 Participants
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Core Study Period Initiation/ Increase, End of Treatment Planned	0 Participants	1 Participants
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Core Study Period Initiation/ Increase, Other Reason	0 Participants	1 Participants
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Core Study Period Decrease, Adverse Event	1 Participants	0 Participants
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Core Study Period Decrease, Lack of Efficacy	0 Participants	1 Participants
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Core Study Period Decrease, End of Treatment Planned	2 Participants	3 Participants
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Core Study Period Decrease, Other Reason	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose (overall up to 88 weeks)

Population: LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Percentage of participants with a discontinuation in corticosteroid dosage during study is reported. The discontinuations were categorized as either permanent or temporary. Participants with temporary discontinuation first followed by permanent discontinuation were counted in both categories. Participants who were receiving corticosteroids at Baseline were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=40 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With Discontinuations of Corticosteroid Dosage During Study Permanent Discontinuation	10.0 percentage of participants	—
Percentage of Participants With Discontinuations of Corticosteroid Dosage During Study Temporary Discontinuation	15.0 percentage of participants	—

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose (overall up to 88 weeks)

Population: LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Time to permanent discontinuation in corticosteroid dosage during study is reported. Participants who permanently discontinued corticosteroids at any time during entire study were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=4 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Time to Permanent Discontinuation of Corticosteroid Dosage During Study	202 days Interval 107.0 to 328.0	—

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose (overall up to 88 weeks)

Population: LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Time to first temporary discontinuation in corticosteroid dosage during study is reported. Participants who temporarily discontinued corticosteroids at any time during entire study were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=6 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Time to First Temporary Discontinuation of Corticosteroid Dosage During Study	147 days Interval 96.0 to 290.0	—

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose (overall up to 88 weeks)

Population: LTE population

Percentage of participants with a change in corticosteroid dosage during study compared to Baseline is reported. The change included either an initiation/ increase (\>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (\</=-5mg/day prednisone or equivalent) of corticosteroid dosage.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=64 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With Change in Corticosteroid Dosage During Study Initiation/ Increase	3.1 percentage of participants	—
Percentage of Participants With Change in Corticosteroid Dosage During Study Decrease	21.9 percentage of participants	—

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose (overall up to 88 weeks)

Population: LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories.

Time to first change in corticosteroid dosage during study compared to Baseline is reported. The change included either an initiation/ increase (\>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (\</=-5mg/day prednisone or equivalent) of corticosteroid dosage. Participants with a change in corticosteroid dosage during entire study were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=16 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Time to Change in Corticosteroid Dosage During Study Initiation/ Increase	44 days Interval 38.0 to 50.0	—
Time to Change in Corticosteroid Dosage During Study Decrease	210 days Interval 96.0 to 428.0	—

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose (overall up to 88 weeks)

Population: LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories.

Number of participants according to reasons for a change in corticosteroid dosage during study compared to Baseline is reported. The change included either an initiation/ increase (\>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (\</=-5mg/day prednisone or equivalent) of corticosteroid dosage. Participants with a change in corticosteroid dosage during entire study were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=16 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Study Initiation/ Increase, Lack of Efficacy	1 Participants	—
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Study Initiation/ Increase, Other Reason	1 Participants	—
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Study Decrease, Lack of Efficacy	1 Participants	—
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Study Decrease, End of Treatment Planned	4 Participants	—
Number of Participants According to Reasons for Change in Corticosteroid Dosage During Study Decrease, Other Reason	9 Participants	—

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Number of participants according to reasons for changes in csDMARDs treatment during core study period is reported. The changes included Increase of dose (the dose increase had to be greater than the highest dose received within the 4 weeks on or before baseline); Addition of another csDMARD (without suppression of the first one); Switch (add and suppression) of a csDMARD for another reason than intolerance to the csDMARD suppressed; Modification of the administration route of MTX (with increase or maintenance of the dose): per oral route to intravenous (IV)/ intramuscular (IM)/ SC. Participants with a change in csDMARDs treatment during core study period were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=29 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Core Study Period Adverse Event	19 Participants	—
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Core Study Period End of Treatment Planned	2 Participants	—
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Core Study Period Lack of Efficacy	1 Participants	—
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Core Study Period Poor Treatment Compliance	1 Participants	—
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Core Study Period Other Reason	6 Participants	—

SECONDARY outcome

Timeframe: Screening up to 8 weeks after last dose (overall up to 88 weeks)

Population: LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Number of participants according to reasons for changes in csDMARDs treatment during study is reported. The changes included Increase of dose (the dose increase had to be greater than the highest dose received within the 4 weeks on or before baseline); Addition of another csDMARD (without suppression of the first one); Switch (add and suppression) of a csDMARD for another reason than intolerance to the csDMARD suppressed; Modification of the administration route of MTX (with increase or maintenance of the dose): per oral route to IV/IM/SC. Participants with a change in csDMARDs treatment during entire study were only included in the analysis.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=12 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Study Adverse Event	5 Participants	—
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Study End of Treatment Planned	1 Participants	—
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Study Lack of Efficacy	2 Participants	—
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Study Poor Treatment Compliance	1 Participants	—
Number of Participants According to Reasons for Changes in csDMARDs Treatment During Study Other Reason	3 Participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories.

Synovitis was assessed by ultrasonographic evaluation (B-mode ultrasound) and scored from "0" to "3" for each 7 paired joints (wrists on both sides, 2nd and 3rd metacarpo-phalangeal \[MCP 2/3\] on both sides, 2nd and 3rd proximal inter-phalangeal \[PIP 2/3\] on both sides, 2nd and 5th metatarsophalangeal \[MTP 2/5\] on both sides). Synovitis total score was calculated by adding the sum of scores for each joint for a total score ranging from 0 to 42. A score of 0 indicated no damage and a score of 42 indicated most severe damage. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=74 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Synovitis Ultrasound B-Mode Score at Week 24 Baseline	14.0 units on a scale Interval 2.0 to 37.0	—
Change From Baseline in Synovitis Ultrasound B-Mode Score at Week 24 Change at Week 24	-8.0 units on a scale Interval -29.0 to 8.0	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24

Population: FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories.

Synovitis was assessed by ultrasonographic evaluation (Power-Doppler-mode ultrasound) and scored from "0" to "3" for each 7 paired joints (wrists on both sides, 2nd and 3rd metacarpo-phalangeal \[MCP 2/3\] on both sides, 2nd and 3rd proximal inter-phalangeal \[PIP 2/3\] on both sides, 2nd and 5th metatarsophalangeal \[MTP 2/5\] on both sides). Synovitis total score was calculated by adding the sum of scores for each joint for a total score ranging from 0 to 42. A score of 0 indicated no damage and a score of 42 indicated most severe damage. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=74 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Change From Baseline in Synovitis Ultrasound Power-Doppler Mode Score at Week 24 Baseline	5.0 units on a scale Interval 0.0 to 26.0	—
Change From Baseline in Synovitis Ultrasound Power-Doppler Mode Score at Week 24 Change at Week 24	-4.0 units on a scale Interval -21.0 to 11.0	—

SECONDARY outcome

Timeframe: Baseline up to 8 weeks after last study drug administration (up to Week 84)

Population: FAS

Percentage of participants with a positive response to anti-therapeutic antibodies against tocilizumab by confirmatory assays at any time during the study is reported.

Outcome measures

Outcome measures
Measure	TCZ - All Participants - Core Study Period n=139 Participants Participants in core study period received TCZ at a dose of 162 mg as SC injection once a week as monotherapy or in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.	TCZ COMBO - Core Study Period Participants who received treatment with MTX or other csDMARDs 4 weeks prior first TCZ administration and/or received TCZ at a dose of 162 mg as SC injection once a week in combination with MTX or other csDMARDs (at investigator's discretion) for 24 weeks.
Percentage of Participants With Anti-Therapeutic Antibodies to Tocilizumab	3.6 percentage of participants	—

Adverse Events

TCZ MONO - All Participants

Serious events: 5 serious events

Other events: 28 other events

Deaths: 0 deaths

TCZ COMBO - All Participants

Serious events: 11 serious events

Other events: 65 other events

Deaths: 0 deaths

TCZ - All Participants

Serious events: 16 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

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