Spots Global Cancer Trial Database for Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

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Trial Identification

Brief Title: Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

Official Title: Post-Authorization Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan

Study ID: NCT03348046

Conditions

Rheumatoid Arthritis

Interventions

Biosimilar Infliximab

Study Description

Brief Summary: The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with rheumatoid arthritis(RA) in Jordan where no visits or intervention(s) additional to the daily practice will be performed

Detailed Description: A multi-center, observational, prospective, cohort study to assess the safety and effectiveness of biosimilar Infliximab (Remsima®) in patients with rheumatoid arthritis in Jordan. Biologic naïve patients will receive Remsima® in accordance with standard medical care and the approved label and will be followed over a period of 34 weeks (8.5 months). Outcomes including occurrence of adverse events (AEs), mean changes in disease activity and health assessment in each cohort will be measured and compared