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

Rheumatoid Arthritis Clinical Trial

— BENEFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100734
• Other study ID #: EUR-BNP-16-11030
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: February 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Axial Spondyloarthritis
• Rheumatoid Arthritis
• Spondylarthritis

Intervention

Biological:
• Benepali
As specified in the treatment arm
• Enbrel
As specified in the treatment arm

Locations

Country	Name	City	State
Germany	Research Site	München	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Samsung Bioepis Co., Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from transition point in Disease Activity Score (DAS-28 score)	Score of 28 joints examined	Approximately 3 months after the transition
Primary	Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score	Mean BASDAI score	Approximately 3 months after the transition
Secondary	Change in the DAS-28 score over time from the value obtained at the Transition Point	Score of 28 joints examined	Approximately 3 and 6 months after the transition
Secondary	Proportion of participants with low disease activity or remission over time following Transition Point	Defined as DAS-28 score = 3.2 or = 2.6	Approximately 3 and 6 months after the transition
Secondary	Proportion of participants with worsening disease over time following Transition Point	Defined by an increase in DAS-28 of = 1.2, and a minimum DAS score of 3.2	Approximately 3 and 6 months after the transition
Secondary	Proportion of participants with an improvement of = 1.2 points in DAS-28 score from Transition Point	Improvement of = 1.2 points in DAS-28 score data collected	Approximately 3 and 6 months after the transition
Secondary	Change in the General Health Score (assessed using VAS) over time following transition point	Assessed using Visual Analogue Scale (VAS) over time	Approximately 3 and 6 months after the transition
Secondary	Change in the BASDAI score over time from the value obtained at the Transition Point	BASDAI score	Approximately 3 and 6 months after the transition
Secondary	Change in Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate (ASDAS-ESR ) or C-Reactive Protein (CRP) score over time from the value obtained at the Transition Point	(ASDAS-ESR ) or (CRP) score	Approximately 3 and 6 months after the transition
Secondary	Proportion of participants with worsening disease over time following Transition Point	Defined by an increase in ASDAS score of =1.1, and a minimum ASDAS score of 2.1	Approximately 3 and 6 months after the transition
Secondary	Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity	Safety surveillance	Approximately 3 and 6 months after the transition
Secondary	Change in Patient Global Assessment (PtGA)-Disease activity-VAS score over time from the value obtained at the Transition Point	Assessed using Disease activity-VAS score	Approximately 3 and 6 months after the transition
Secondary	Change in Patient Global Assessment - Visual Analogue Scale (PGA PAIN-VAS) score over time from the value obtained at the Transition Point	Assessed using PAIN-VAS score	Approximately 3 and 6 months after the transition
Secondary	Change in Patient PGA FATIGUE -VAS score over time from the value obtained at the Transition Point	Assessed using FATIGUE - VAS score	Approximately 3 and 6 months after the transition
Secondary	Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score over time from the value obtained at the Transition Point	Assessed using the HAQ-DI score	Approximately 3 and 6 months after the transition
Secondary	Change in PAIN-VAS score over time from the value obtained at the Transition Point	Assessed using Pain - VAS score	Approximately 3 and 6 months after the transition
Secondary	Change in FATIGUE -VAS score over time from the value obtained at the Transition Point	Assessed using FATIGUE - VAS score	Approximately 3 and 6 months after the transition
Secondary	Change in HAQ-DI score over time from the value obtained at the Transition Point	Assessed using the HAQ-DI score	Approximately 3 and 6 months after the transition
Secondary	Number of Participants by Demographic Category		At baseline and approximately 3 and 6 months after the transition
Secondary	Number of Participants by Relevant Medical History		At baseline and approximately 3 and 6 months after the transition
Secondary	Number of Participants by Disease Status		At baseline and approximately 3 and 6 months after the transition
Secondary	Number of Participants by Relevant Medication Use		At baseline and approximately 3 and 6 months after the transition

External Links

•   Manuscript description