An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. AESIs included serious infections (including opportunistic infections) and abnormal liver function tests.

Full Analysis Set (FAS) included all randomized participants enrolled in the study who received at least one dose of tocilizumab.

An AE is any untoward medical occurrence in a study participant given administered a pharmaceutical product, regardless of the cause of the AE.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab.

The DAS28-ESR Scale is a measure of a participant's disease activity. It is based on tender joint count (28 joints), swollen joint count (28 joints), a participant's assessment of disease activity, and erythrocyte sedimentation rate. DAS28-ESR is expressed as a score on a scale with a minimum score of 0 (low disease activity ) to a maximum score of 10 (high disease activity). A negative mean percent change from baseline indicates a decrease in disease activity, and a positive mean percent change from baseline indicates an increase in disease activity.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab. Here, number of participants analyzed is the total participants who were evaluable for this outcome measure, and 'n' is the total number of participants who were evaluated at a specific time point.

The Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC), based on a 28-joint assessment, patient and physician global assessment assessed on 0-10 centimeter (cm) visual analogue scale (VAS), where 0 = no disease activity and 10 = worst disease activity, and level of C-reactive protein (CRP, mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. A negative mean percent change from baseline indicates a decrease in disease activity, and a positive mean percent change from baseline indicates an increase in disease activity.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab. Here, number of participants analyzed is the total participants who were evaluable for this outcome measure, and 'n' is the total number of participants who were evaluated at a specific time point.

Number of tender joints was determined by examination of 66 joints, as assessed through pressure and passive joint motion during physical examination.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab. Here, 'n' is the total number of participants who were evaluated at a specific time point.

Number of swollen joints was determined by examination of 66 joints, as assessed through pressure and passive joint motion during physical examination.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab. Here, 'n' is the total number of participants who were evaluated at a specific time point.

Treatment-free remission is remission at two consecutive assessment visits (every 12 weeks) after discontinuing study drug on the second assessment visit. Clinical remission is DAS28-ESR score <2.6 and/or SDAI score ≤3.3. The DAS28-ESR scale is a measure of a participant's disease activity based on tender joint count (28 joints), swollen joint count (28 joints), a participant's assessment of disease activity, and ESR. DAS28-ESR scored on a scale with a minimum score of 0 (low disease activity) to a maximum score of 10 (high disease activity). The SDAI is sum of TJC and SJC, based on a 28-joint assessment, patient and physician global assessment assessed on 0-10 centimeter visual analogue scale (VAS), where 0 = no disease activity and 10 = worst disease activity, and level of C-reactive protein (CRP, mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11=low disease activity, >11 to 26=moderate disease activity, and >26=high (or severe) disease activity.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab.

Time to rheumatoid arthritis (RA) recurrence = period from treatment-free remission to RA recurrence. RA recurrence was worsening of disease activity with treatment beyond supportive therapy.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab. Analysis was performed on those participants who achieved treatment-free remission.

The participant's overall assessment of their current disease activity was displayed on a 100-millimeter (mm) horizontal VAS. The left-hand extreme (0 mm) of the line was described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity" (maximum arthritis disease activity). The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab. Here, number of participants analyzed is the total participants who were evaluable for this outcome measure and 'n' is the total number of participants who were evaluated at specific time point.

Participants' pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab. Here, number of participants analyzed is the total participants who were evaluable for this outcome measure and 'n' is the total number of participants who were evaluated at specific time point.

The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.

FAS included all randomized participants enrolled in the study who received at least one dose of tocilizumab. Here, number of participants analyzed is the total participants who were evaluable for this outcome measure and 'n' is the total number of participants who were evaluated at specific time point.