A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

European Quality of Life - 5 Dimensions (EQ-5D) Score

EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24

Change in EQ-5D Score at Week 24 From Baseline

EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (\<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D \<0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.

Time frame: Baseline and Week 24

General Health Score as Assessed by EQ-5D VAS

Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.

Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24

Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D

Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.

Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24

Change in General Health Assessed by VAS

Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.

Time frame: Baseline and Week 24

Disease Activity Score Based on 28-Joint Count (DAS28)

DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.

Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24

Change in DAS28 Score From Baseline to Week 24

Time frame: Baseline and Week 24

Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment

DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR mm/hour, and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than \[\<\] 2.6), I=low (DAS28 less than or equal to \[≤\]2.6 to \<3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than \[\>\]5.1).

Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response

ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase response: C-reactive protein (CRP) or ESR.

Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24

Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28

The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline \>1.2 with DAS28 score ≤3.2; moderate effect: change from baseline \>1.2 with DAS28 score 3.2 to 5.1 or change from baseline \>0.6 to \<1.2 with DAS28 score \<3.2; no effect: change from baseline ≤0.6 or change from baseline \>0.6 and ≤1.2 with DAS28 score \>5.1.

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

C-Reactive Protein

CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.

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

Erythrocyte Sedimentation Rate

ESR (mm/hr) is used to determine the acute phase response.

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