A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit

Percentage of Participants Discontinuing Tocilizumab for Any Reason

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit

Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit

DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (\<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference.

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit

Percentage of Participants Achieving a DAS28 Score <3.2 by Visit

DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 \>3.2 to 5.1=moderate to high disease activity; DAS28 \<2.6=remission.

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit

Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)

DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 \>3.2 to 5.1=moderate to high disease activity; DAS28 \<2.6=remission.

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit

DAS28 Score by Visit

DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 \>3.2 to 5.1=moderate to high disease activity; DAS28 \<2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value.

Time frame: Weeks 4, 8, 12, 16, 20, and Final Visit

Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response)

ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein \[CRP\])

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit

Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response)

ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit

Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response)

ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit

Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response)

ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit

C-Reactive Protein (CRP) Levels

CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L).

Time frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit

Erythrocyte Sedimentation Rate

ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement.

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

HAQ-DI Score by Visit

HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.

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

Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI

HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.

Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit