An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA

* Hepatitis B virus reactivation * Congestive heart failure * Opportunistic infections (excluding tuberculosis) * Serious infections including sepsis (excluding opportunistic infections and tuberculosis) * Tuberculosis (TB) * Serum sickness (delayed hypersensitivity reactions) * Haematological reactions * Systemic lupus erythematosus/lupus-like syndrome * Demyelinating disorders * Lymphoma (not hepatosplenic T cell lymphoma) * Hepatobiliary events * Hepatosplenic T cell lymphoma (HSTCL) * Serious infusion reactions during a re-induction regimen following disease flare * Sarcoidosis/sarcoid-like reactions * Leukaemia * Malignancy (excluding lymphoma) * Skin cancer * Pregnancy exposure * Infusion reactions associated with shortened infusion duration * Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction

Time frame: Duration of study participation (up to 5 years)

Population: The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used. All patients data were analyzed; however, there were 0 patients recruited in the Switch to Remicade I and Switch to Remicade II groups.

The arthritis-related functional disability will be measured using the disability index of the Health Assessment Questionnaire (HAQ), a validated, self-administered form that assesses functional ability in a number of relevant areas, including the ability to dress, rise from bed, eat, walk, maintain personal hygiene, reach, grip and other activities on a scale ranging from 0 (without any difficulty) to 3 (unable to do). Scores range from 0 to 3, with higher scores indicating worse disability. There are 8 categories within the Health Assessment Questionnaire. The answer to each question will be scored as follows: Without any difficulty = 0, With some difficulty = 1, With much difficulty = 2, Unable to do = 3. Divide the summed category scores (using the adjustment score) by the number of categories answered to obtain the HAQ estimate of physical ability.

Time frame: Day 0 ~ Week 198 (every 6 months ±6 weeks)

Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.

Disease activity score in 28 joints (DAS28) will be calculated in two ways using the following two equations: DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln(ESR)) + (0.014 × GH); DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln(CRP + 1)) + (0.014 × GH) + 0.96 Where: TJC28 = number of tender joints (0-28): tender joint count (TJC); SJC28 = number of swollen joints (0-28): swollen joint count (SJC); ESR = ESR measurement (mm/h); CRP = CRP measurement (mg/L); GH = Patient Global Assessment of Disease Activity measured on VAS (0 - 100 mm) Disease activity is indexed as follows, on a 10 point scale, with higher numbers indicating worse disease activity: Remission: DAS28 \< 2.6 Low Disease Activity: 2.6 ≤ DAS28 \< 3.2 Moderate Disease Activity: 3.2 ≤ DAS28 ≤ 5.1 High Disease Activity: 5.1 \< DAS28

Time frame: Day 0 ~ Week 198 (every 6 months ±6 weeks)

Population: The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups.