A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Time frame: Week 104

Population: Safety population: included all participants who have received any part of an infusion of the study medication.

DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour \[mm/hr\]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment \[VAS\]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (\>) 3.2 to 5.1 = moderate to high disease activity.

Time frame: Day 1 and Week 24

Population: ITT population

DAS28-based EULAR response criteria were used to measure individual response as no response, 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 less than or equal to (≤)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: Screening, Day 1, and Weeks 24 and 104

Population: ITT population

Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available.

Time frame: Screening, Weeks 48 and 104

Population: ITT population