A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate

Percentage of Participants Achieving Remission at Week 16 Assessed Using DAS28-ESR

The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR less than (\<) 2.6

Time frame: Week 16

Percentage of Participants by European League Against Rheumatism (EULAR) Response Category at Week 16

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 (greater than) \>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to ≤5.1 or DAS28-ESR \>5.1 or change from baseline \>0.6 to ≤1.2 with DAS28 ≤5.1; nonresponders: change from baseline ≤0.6 or change from baseline \>0.6 and ≤1.2 with DAS28 \>5.1.

Time frame: Week 16

Change From Baseline in DAS28-ESR

The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR scores were calculated as follows: DAS28-ESR = (0.56 \* √TJC)+(0.28 \* √SJC)+(0.70 \* ln(ESR))+(0.014 \* GH). No imputation used for tender and swollen joint counts, ESR, and patient's global assessment of disease activity VAS.

Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48

Clinical Disease Activity Index Scores

The Clinical Disease Activity Index (CDAI) score was calculated according to the following formula: CDAI = SJC + TJC + GH/10 + EGA/10 Where: SJC = swollen joint count based on 28 joints; TJC = tender joint count based on 28 joints; GH = Participant's global assessment of disease activity; EGA = evaluator's (physician's) global assessment of disease activity. CDAI scores range from 0-76 and the following cut-off points for different disease activity states have been used: high disease activity \>22; moderate disease activity \>10 and ≤22; LDA \>2.8 and ≤10; and remission ≤ 2.8. No imputation used for TJC, SJC, Patient's Global Assessment of Disease Activity VAS and Physicians global assessment of disease activity VAS.

Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48

Simplified Disease Activity Index (SDAI) Scores

The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), Participant and Physician assessed global disease activity (assessed on 0-100 mm VAS; higher scores = greater affection due to disease activity), and ESR (mm/hour). SDAI total score ranged from 0 to 86. Higher scores indicated greater disease activity.

Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48

Change From Baseline to Week 48 in SJC and TJC

An assessment of 28 joints for swelling and tenderness will be made. Joints will be assessed and classified as swollen (1)/not swollen (0) and tender(1)/not tender (0) by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. The 28 joints assessed comprise shoulders (2 joints), elbows (2 joints), wrists (2 joints), metacarpophalangeal joints on digits 1-5 (10 joints), interphalangeal on digit 1 (2 joints), proximal interphalangeal joints on digits 2-5 (8 joints), and knees (2 joints).

Time frame: Baseline and Week 48

Change From Baseline to Week 48 in Health Assessment Questionnaire (HAQ)

The Stanford Health Assessment Questionnaire disability index specific for rheumatoid arthritis was completed by the participants for efficacy assessments.

Time frame: Baseline and Week 48

Change From Baseline to Week 48 in C-Reactive Protein (CRP)

CRP is an acute phase reactant and is a measure of inflammation.

Time frame: Baseline and Week 48

Change From Baseline to Week 48 in ESR

ESR is an acute phase reactant and is a measure of inflammation.

Time frame: Baseline and Week 48

Change From Baseline to Week 48 in Physician's Global Assessment of Disease Activity

Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm= maximum disease activity. The physician marked the line according to their assessment and the distance from the left edge was measured.

Time frame: Baseline and Week 48

Change From Baseline to Week 48 in Participant's Global Assessment of Disease Activity

Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = maximum disease activity. The participant marked the line according to their assessment and the distance from the left edge was measured.

Time frame: Baseline and Week 48

Change From Baseline to Week 48 in Participant's Assessment of Pain

Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no pain and 100 mm = maximum pain. The participant marked the line according to their assessment and the distance from the left edge was measured.

Time frame: Baseline and Week 48