A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Percentage of participants with a serious adverse event (SAE), who died, with an adverse event (AE), or study drug related AE during the study.

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

Population: All the participants who were administered treatment at each visit were considered during the analysis.

CRP is an acute phase inflammatory marker. The serum concentration of CRP is measured in milligrams per liter (mg/L). A reduction in the level is considered an improvement.

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

Population: All the participants who were administered treatment at each visit were considered during the analysis.

ESR (measured in mm/hr) is an inflammation marker used to determine acute phase response.

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

Population: All the participants who were administered treatment at each visit were considered during the analysis.

HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3..

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

Population: All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered

DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) 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. Participants achieved a clinically meaningful improvement in DAS28 if there was a reduction of at least 1.2 units from baseline.

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

Population: All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered

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 \[mm/hr\]) and global health assessment (participant rated global assessment of disease activity using 10-mm Visual analog scale - VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A DAS28 score of greater than (\>)5.1 indicated high disease activity, a score of \>3.2 but less than or equal to (≤)5.1 indicated moderate disease activity, a score of greater than or equal to (≥)2.6 but ≤3.2 indicated low disease activity, and a score of less than \<2.6 indicated disease remission. Week 24 is the Follow-Up visit.

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

Population: All the participants who were administered treatment at each visit were considered during the analysis.~n (number) at Week 24 equals (=) number of participants in that visit; n at Other Visits = number of participants with treatment administered

HAQ includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.

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

Population: All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered

Physical function scoring was as follows with respect to performance of participant's everyday activities: 0=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. The HAQ-DI score at every visit was categorized into none to mild disability (HAQ-DI \<1), moderate disability (1≤ HAQ-DI \<2) and severe disability (HAQ-DI ≥2). The percentages of the participants falling in each of these categories with respect to the visits were determined.

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

Population: All the participants who were administered treatment at each visit were considered during the analysis.~n at Week 24 = number of participants in that visit; n at Other Visits = number of participants with treatment administered

Time to response is the number of days from date of first infusion to date of event. DAS28 response was defined as achievement of Low Disease Activity (DAS28 ≥2.6 to ≤3.2), Remission (DAS28 \<2.6), or Clinically Meaningful Improvement (change of \>1.2 from baseline).

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

Population: All the participants who were administered treatment at each visit were considered during the analysis.