NCT02557295

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 248 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.

Detailed description

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with RA in comparison with patients receiving non-biologic treatmentsor other anti-TNF drugs. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment (3 mg/kg of RemsimaTM by IV infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). For patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier.

Conditions

• Rheumatoid Arthritis

Timeline

• Start date: 2013-12-17
• Primary completion: 2020-03-02
• Completion: 2020-03-02
• First posted: 2015-09-23
• Last updated: 2024-11-26
• Results posted: 2024-02-05