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

Summary

Participation Requirements

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...

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.

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