An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Sero-Positive Rheumatoid Arthritis Who Are Non-Responders or Intolerant to a Single TNF-Inhibitor (PORTSMAB)

Mean Change From Baseline in Physician's Global Assessment of Disease Activity At Month 24

The Physician's Global Assessment of disease activity was assessed using a Visual Analogue Scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

Time frame: Baseline (Day 0) and Month 24

Mean Change From Baseline in Patient's Global Assessment of Disease Activity at Month 24

The Patient's Global Assessment of disease activity was assessed using VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).Change from Baseline = score at observation minus score at Baseline. An increase in score from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

Time frame: Baseline (Day 0) and Month 24

Mean Change From Baseline in Severity of Pain at Month 24

The patient's assessment of pain was performed using a 100 mm VAS ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.

Time frame: Baseline (Day 0) and Month 24

Mean Change Form Baseline in Functional Capacity at Month 24

The functional capacity was analyzed using Health Assessment Questionnaire-Disability Index (HAQ-DI). It is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 domains (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each domain are scored from 0 to 3 (0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do). Overall score was computed as sum of domain scores and divided by the number of domains. A total possible score ranged from 0 (best) to 3 (worst).

Time frame: Baseline (Day 0) and Month 24

Reason for Change From First TNF-inhibitor Therapy to Rituximab

Adverse event, primary and secondary insufficient responses and monoclonal gammopathy were the reasons for starting rituximab therapy.

Time frame: At Screening

Number of Participants on Each Pattern of Re-treatment

There are two patterns of re-treatment, namely treat-to-target and according to the clinic. Treat-to-target: a new cycle every 6 months if not in remission, with the participant receiving no new course of treatment as long as he is in remission. On demand (according to clinic): a new cycle when, in an assessment performed at least 16 weeks after the last treatment cycle, the participant shows moderate or high disease activity \[DAS28 \> 3.2 or difference in DAS28 (ΔDAS28) \> 0.6\]

Time frame: Up to Month 24

Number of Participants With Incidence of Infusion Reactions or Injection Site Reactions

An infusion reaction or injection site reaction is an event that occurs after infusion or injection which may include hypersensitivity reactions or anaphylactic reactions.

Time frame: At Months 6, 12 and 24

Number of Participants With Incidence of Infectious Events

Follow-up of the infectious events was done after Month 6 visit, Month 12 visit and Month 24 visit.

Time frame: At Months 6, 12 and 24

Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events

An Adverse Events (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect

Time frame: Up to Month 24