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Clinical Trial 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


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03348046
Study type Observational
Source Hikma Pharmaceuticals LLC
Contact
Status Completed
Phase
Start date March 23, 2017
Completion date April 14, 2019

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