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

Study Overview
=================
Brief Summary
-----------------
An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.

Detailed Description
-----------------
The primary objective of this study is to assess the long-term safety of Remsima™ in Rheumatoid Arthritis (RA) patients by evaluation of events of special interest (ESI) up to 5 years and to exploratory compare patients receiving Remsima™ with patients receiving non-biologic treatments or other anti-TNF drugs. In order to assess the primary study outcomes, the following ESI will be evaluated: Hepatitis B virus reactivation Congestive heart failure Opportunistic infection (excluding tuberculosis) Serious infections including sepsis (excluding opportunistic infections and tuberculosis) Tuberculosis (TB) Serum sickness (delayed hypersensitivity reactions) Haematologic reactions Systemic lupus erythematosus/lupus like syndrome Demyelinating disorders Lymphoma (not HSTCL) 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 reaction associated with shortened infusion duration Others The secondary objectives of this study are to evaluate efficacy. Further, additional safety of Remsima™ in RA patients, in comparison with patients receiving non-biologic treatments or other anti-TNF drugs. Health-economics parameters will also be assessed.

Official Title
-----------------
An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Patients with active RA Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records Exclusion Criteria: Patients with a history of hypersensitivity to infliximab Patients with a current or past history of chronic infection Patients with moderate or severe heart failure (NYHA class III/IV).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Remsima™<br>Patients who are taking Remsima™ for the treatment | |
| Other anti-TNF drugs<br>Patients who are taking other anti-TNF drugs such as infliximab (Remicade®), etanercept, adalimumab, etc. | |
| Biologic naive patients<br>Biologic naive patients (in Korea only) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of events of special interest in RA patients |  | every visit, up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score 28 (DAS28) |  | every 6 months, up to 5 years | 
| Health Assessment Questionnaire (HAQ) |  | every 6 months, up to 5 years |