NCT03100734

Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel

A Multicentre Observational Study to Evaluate the Real-Life Effectiveness of Benepali® Following Transition From Enbrel® in Patients With Rheumatoid Arthritis (RA) and Axial Spondyloarthritis (axSpA) - The BENEFIT Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 585 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the effectiveness of Benepali in participants with Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from treatment with Enbrel. The secondary objectives of this study are to describe clinical characteristics of patients transitioned from Enbrel® to Benepali® in routine practice, to evaluate safety during and following the transition from Enbrel to Benepali and to evaluate patient-reported outcomes during and following the transition from Enbrel to Benepali.

Conditions

• Rheumatoid Arthritis
• Axial Spondyloarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Benepali	As specified in the treatment arm
BIOLOGICAL	Enbrel	As specified in the treatment arm

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2017-04-04
• Last updated: 2021-02-05

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study