A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.

Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was 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 100-mm Visual analog scale \[VAS\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.

Time frame: Week 24

Population: ITT population.

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 100-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

Time frame: Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Population: ITT Population; only participants with a DAS28 value at baseline were included in the analysis.

CDAI was calculated according to the following formula: CDAI = Number of swollen joints (plus) + Number of tender joints + VAS disease activity participant assessment + VAS disease activity investigator assessment. The maximum score was 334 (66 joints + 68 joints + 100 mm + 100 mm); higher scores indicated higher disease activity.

Time frame: Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Population: ITT population; only participants with values for CDAI at baseline and the respective visit were included in the analysis.

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater 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). A higher score reflects an improvement in the participant's health status.

Time frame: Week 24

Population: ITT Population; Missing data were imputed using LOCF.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame: Week 24

Population: ITT Population; Missing data were imputed using LOCF.

Participant's global assessment of disease activity was an overall assessment of their current disease activity on a 100-mm horizontal VAS scale (left-hand extreme: no disease activity; right-hand extreme: maximum disease activity). Physician's global assessment of disease activity was measured as participant's current disease activity on a 100-mm horizontal VAS scale (left hand extreme: no disease activity; right-hand extreme: maximum disease activity).

Time frame: Week 24

Population: ITT Population; missing data were imputed using LOCF.

Participant's global assessment of pain was assessed using a 100-mm horizontal VAS (0 to 100 mm) with 0=pain absent and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their current level of pain.

Time frame: Week 24

Population: ITT Population; missing data were imputed using LOCF.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Absolute change was defined as the change from baseline to Week 24.

Time frame: Week 24

Population: ITT Population; Missing data were imputed using LOCF.

Swollen joint count: 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. Tender joint counts: 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.

Time frame: Week 24

Population: ITT Population; missing data were imputed using last observation carried forward (LOCF).

The serum concentration of CRP is measured in mg/L. A reduction in the level was considered an improvement.

Time frame: Week 24

Population: ITT Population; missing data were imputed using LOCF.

CRP is an acute phase inflammatory marker used as a measure of inflammation. A reduction in CRP is considered to be an improvement.

Time frame: Baseline, Weeks 1, 2 ,4 and 24

Population: ITT Population

ESR is an inflammation marker used to determine acute phase response.

Time frame: Baseline, Weeks 1, 2, 4 and 24

Population: ITT Population.

Hemoglobin levels were determined as a hematology parameter to measure changes in disease related anemia.

Time frame: Baseline, Weeks 1, 2, 4 and 24

Population: ITT Population.

Duration of morning stiffness: participants were asked 'how long did your morning stiffness last from the time you woke up yesterday' and the response was provided in minutes and hours. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.

Time frame: Baseline, Weeks 1, 2, and 4

Population: ITT Population; Missing data were imputed using LOCF.

Participants were asked to assess their overall level of fatigue/tiredness during the previous 24 hours using a 100-mm horizontal VAS with 0=none and 100=very severe. Participants responded by placing a mark on the line to indicate their current level of fatigue. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.

Time frame: Baseline and Weeks 1, 2 and 4

Population: ITT Population; Missing data were imputed using LOCF.

Participant's were asked to state the worst level of pain felt in the past 24 hours using a 100-mm horizontal VAS (0 to 100 mm) with 0=no pain and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their level of pain. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.

Time frame: Baseline and Weeks 1, 2, and 4

Population: ITT Population; Missing data were imputed using LOCF.

DAS28 calculated from the number of swollen joints and painful joints using the 28-joint count, the ESR and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment using VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 = low disease activity, DAS28 \<2.6 = remission and a clinically significant (CS) reduction was defined as ≥1.2.

Time frame: Weeks 4 and 24

Population: ITT Population;

ACR20/50/70 response: ≥20%, 50%, or 70% improvement, respectively, in swollen and tender joint count; and ≥20% improvement 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 Health Assessment Questionnaire \[HAQ-DI\]); and C-Reactive Protein (CRP).

Time frame: Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Population: ITT Population

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to ≤5.1 or change from baseline \>0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤ 0.6 or change from baseline \>0.6 and ≤1.2 with DAS28 \>5.1.

Time frame: Week 24

Population: ITT Population

Participants who withdrew from study drug due to other reasons were not taken into account.

Time frame: Weeks 1, 2, 4, 8, 12, 16, 20 and 24

Population: ITT Population; participants who withdrew from study drug due to other reaasons were not included in the analysis.

The TSQM is a general measure of participants treatment satisfaction and consists of 14 questions that result in 4 subscales: effectiveness, side-effects, convenience and global satisfaction. All subscale scores range from 0 to 100%, with 100% being the best possible result.

Time frame: Week 24

Population: ITT Population