NCT02557308

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 329 (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 Ankylosing Spondylitis

Detailed description

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with AS in comparison with patients receiving other TNF blockers. 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. 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. For switched patients, their assessment schedule will be re-started from the day of switch. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.

Conditions

• Ankylosing Spondylitis

Timeline

• Start date: 2015-05-26
• Primary completion: 2021-02-28
• Completion: 2021-02-28
• First posted: 2015-09-23
• Last updated: 2024-12-09
• Results posted: 2024-12-09