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

Biogen585 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

585

Conditions

Rheumatoid Arthritis Axial Spondyloarthritis

Interventions

BenepaliBIOLOGICAL

As specified in the treatment arm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Must have been diagnosed with either rheumatoid arthritis or axial spondyloarthritis, according to local practice * Transition from Enbrel to Benepali at the physician's (Investigator's) discretion prior to enrolment into the study * Must have been treated with the same dose of Enbrel for at least 6 months prior to transition to Benepali and have at least 1 efficacy data value including but not restricted to DAS-28 or BASDAI during that period * Must have a stable disease throughout the 2 month prior to enrolment based on the Investigator's judgement * Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy Key Exclusion Criteria: * Have any medical conditions that precludes administration of Benepali according to Summary of Product Characteristics (SmPC), such as the following: * Hypersensitivity to the Benepali active substance, or to any of the associated excipients * Sepsis, or risk of sepsis * Active clinically significant local or chronic viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 2 months prior to enrollment * Show any clinical sign or medical condition not allowing for treatment continuation (of etanercept) in the judgment of the Investigator * Treatment with another biologic agent * Are currently receiving or have previously received any therapies that would preclude administration of Benepali, such as the following: * Immunizations with live or live-attenuated vaccines within the last 6 months prior to transition point and throughout the observation period * Treatment with investigational agents within the last 6 months prior to transition point and during the period of observation. * Any other unspecified reasons that would, in the opinion of the Investigator, make the patient unsuitable for enrollment. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Outcomes

Primary Outcomes

Change from transition point in Disease Activity Score (DAS-28 score)

Score of 28 joints examined

Time frame: Approximately 3 months after the transition

Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score

Mean BASDAI score

Time frame: Approximately 3 months after the transition