An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour \[ml/hr\]), and Patient's Global Assessment (PGH) of disease activity \[measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity\]. DAS28 was calculated using the following formula: DAS28 = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.

Time frame: Baseline and Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour \[ml/hr\]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale \[VAS\] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.

Time frame: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame: Up to 39 months

Population: Safety population included all participants who received at least one dose of study treatment.

The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\], and ESR. DAS28 total scores range from 0 to 10. DAS28 \<=3.2 indicates low disease activity, DAS28 \>3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline (CFB) indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 \<=3.2 and a CFB \>1.2. Moderate response: DAS28 \<=3.2 and CFB \>0.6 to \<=1.2, DAS28 \>3.2 to \<=5.1 and CFB \>1.2 or \>0.6 to \<=1.2, DAS28 \>5.1 and CFB \>1.2. No response: DAS28 \<=3.2 and CFB \>=0.6, DAS28 \>3.2 to \<=5.1 and CFB \<=0.6, DAS28 \>5.1 and CFB \>0.6 to \<=1.2 or \<=0.6.

Time frame: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour \[ml/hr\]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale \[VAS\] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.

Time frame: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\], and ESR. DAS28 total scores range from 0 to 10. DAS28 \<=3.2 indicates low disease activity, DAS28 \>3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 \<=3.2 and a CFB \>1.2. Moderate response: DAS28 \<=3.2 and CFB \>0.6 to \<=1.2, DAS28 \>3.2 to \<=5.1 and CFB \>1.2 or \>0.6 to \<=1.2, DAS28 \>5.1 and CFB \>1.2. No response: DAS28 \<=3.2 and CFB \>=0.6, DAS28 \>3.2 to \<=5.1 and CFB \<=0.6, DAS28 \>5.1 and CFB \>0.6 to \<=1.2 or \<=0.6.

Time frame: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\], and ESR. DAS28 total scores range from 0 to 10. DAS28 \<=3.2 indicates low disease activity, DAS28 \>3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 \<=3.2 and a CFB \>1.2. Moderate response: DAS28 \<=3.2 and CFB \>0.6 to \<=1.2, DAS28 \>3.2 to \<=5.1 and CFB \>1.2 or \>0.6 to \<=1.2, DAS28 \>5.1 and CFB \>1.2. No response: DAS28 \<=3.2 and CFB \>=0.6, DAS28 \>3.2 to \<=5.1 and CFB \<=0.6, DAS28 \>5.1 and CFB \>0.6 to \<=1.2 or \<=0.6.

Time frame: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour \[ml/hr\]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale \[VAS\] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.

Time frame: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\], and ESR. DAS28 total scores range from 0 to 10. DAS28 \<=3.2 indicates low disease activity, DAS28 \>3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline indicates improvement. 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 (CFB) and the level of disease activity reached. Good response: DAS28 \<=3.2 and a CFB \>1.2. Moderate response: DAS28 \<=3.2 and CFB \>0.6 to \<=1.2, DAS28 \>3.2 to \<=5.1 and CFB \>1.2 or \>0.6 to \<=1.2, DAS28 \>5.1 and CFB \>1.2. No response: DAS28 \<=3.2 and CFB \>=0.6, DAS28 \>3.2 to \<=5.1 and CFB \<=0.6, DAS28 \>5.1 and CFB \>0.6 to \<=1.2 or \<=0.6.

Time frame: Week 20

Population: Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.

HAQ is a self-completed patient questionnaire specific for rheumatoid arthritis (RA). It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ the patient must have a domain score for at least 6 of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.

Time frame: Baseline and Week 20

Population: Intent to treat population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated to the screening exam, and have completed the baseline visit and at least one further assessment. Here, number of participant analysed is the participants who were evaluable for this outcome measure.