A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

Time frame: Month 6

Population: ITT.

Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.

Time frame: Baseline, Months 3, 6

Population: ITT. Here number of participants analyzed included evaluable participants for the outcome measure and n included evaluable participants at specified time point.

Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (\>) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of \>0.6 to ≤1.2 points, score of \>3.2 and ≤5.1 with DAS28 improvement of \>0.6 to ≤1.2 points, score of \>3.2 and ≤5.1 with DAS28 improvement of \>1.2 points, score of \>5.1 and DAS28 improvement of \>1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of \>3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of \>5.1 and DAS28 improvement of \>0.6 to ≤1.2 points, score of \>5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.

Time frame: Baseline up to Month 6

Population: ITT.

The CDAI was calculated as \[SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity\]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is 'remission', score \> 2.8 and ≤ 10 is 'low disease activity', score \> 10 and ≤ 22 is 'moderate disease activity', score \> 22 is 'high disease activity'. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.

Time frame: Baseline up to Month 6

Population: ITT.

The SDAI was calculated as \[SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})\]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity'. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is 'remission', score \> 3.3 and ≤ 11 is 'low disease activity', score \> 11 and ≤ 26 is 'moderate disease activity', score \> 26 is 'high disease activity'. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.

Time frame: Baseline up to Month 6

Population: ITT.

Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.

Time frame: Baseline, up to Month 6

Population: ITT.

ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or erythrocyte sedimentation rate\].

Time frame: Month 1, 2, 3, 4, 5, 6

Population: ITT.

Percentage of participants with anti-CCP status were reported as positive, negative and unknown.

Time frame: Baseline up to Day 5

Population: ITT.

The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment (PtGA) of disease activity \[visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity\] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.

Time frame: Baseline, Month 1, 2, 3, 4, 5, 6

Population: ITT.

BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.

Time frame: Baseline up to Day 5

Population: ITT.

Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under unknown.

Time frame: Baseline up to Day 5

Population: ITT.

Percentage of participants with rheumatoid factor status was reported as positive or negative.

Time frame: Baseline up to Day 5

Population: ITT.

Time frame: Baseline up to Month 6

Population: ITT.