Research Site
München, Bavaria, 80639, Germany
NCT Number: NCT03100734
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.
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Notify Me18 year and older
All sexes
Observational
München, Bavaria, 80639, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
As specified in the treatment arm
As specified in the treatment arm
Other names: etanercept
Time frame: Approximately 3 months after the transition
Score of 28 joints examined
Time frame: Approximately 3 months after the transition
Mean BASDAI score
Time frame: Approximately 3 and 6 months after the transition
Score of 28 joints examined
Time frame: Approximately 3 and 6 months after the transition
Defined as DAS-28 score ≤ 3.2 or ≤ 2.6
Time frame: Approximately 3 and 6 months after the transition
Defined by an increase in DAS-28 of ≥ 1.2, and a minimum DAS score of 3.2
Time frame: Approximately 3 and 6 months after the transition
Improvement of ≥ 1.2 points in DAS-28 score data collected
Time frame: Approximately 3 and 6 months after the transition
Assessed using Visual Analogue Scale (VAS) over time
Time frame: Approximately 3 and 6 months after the transition
BASDAI score
Time frame: Approximately 3 and 6 months after the transition
(ASDAS-ESR ) or (CRP) score
Time frame: Approximately 3 and 6 months after the transition
Defined by an increase in ASDAS score of ≥1.1, and a minimum ASDAS score of 2.1
Time frame: Approximately 3 and 6 months after the transition
Safety surveillance
Time frame: Approximately 3 and 6 months after the transition
Assessed using Disease activity-VAS score
Time frame: Approximately 3 and 6 months after the transition
Assessed using PAIN-VAS score
Time frame: Approximately 3 and 6 months after the transition
Assessed using FATIGUE - VAS score
Time frame: Approximately 3 and 6 months after the transition
Assessed using the HAQ-DI score
Time frame: Approximately 3 and 6 months after the transition
Assessed using Pain - VAS score
Time frame: Approximately 3 and 6 months after the transition
Assessed using FATIGUE - VAS score
Time frame: Approximately 3 and 6 months after the transition
Assessed using the HAQ-DI score
Time frame: At baseline and approximately 3 and 6 months after the transition
Time frame: At baseline and approximately 3 and 6 months after the transition
Time frame: At baseline and approximately 3 and 6 months after the transition
Time frame: At baseline and approximately 3 and 6 months after the transition
Biogen
Industry
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
Acronym: BENEFIT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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