Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel
Completed
- Conditions
- Rheumatoid ArthritisAxial Spondyloarthritis
- Interventions
- Biological: BenepaliBiological: Enbrel
- Registration Number
- NCT03100734
- Lead Sponsor
- Biogen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 585
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description With axSpA Benepali Participants with axSpA previously treated with Enbrel and transitioned to Benepali With RA Enbrel Participants with RA previously treated with Enbrel and transitioned to Benepali With RA Benepali Participants with RA previously treated with Enbrel and transitioned to Benepali With axSpA Enbrel Participants with axSpA previously treated with Enbrel and transitioned to Benepali
- Primary Outcome Measures
Name Time Method Change from transition point in Disease Activity Score (DAS-28 score) Approximately 3 months after the transition Score of 28 joints examined
Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score Approximately 3 months after the transition Mean BASDAI score
- Secondary Outcome Measures
Name Time Method Change in the BASDAI score over time from the value obtained at the Transition Point Approximately 3 and 6 months after the transition BASDAI score
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity Approximately 3 and 6 months after the transition Safety surveillance
Change in the DAS-28 score over time from the value obtained at the Transition Point Approximately 3 and 6 months after the transition Score of 28 joints examined
Proportion of participants with low disease activity or remission over time following Transition Point Approximately 3 and 6 months after the transition Defined as DAS-28 score ≤ 3.2 or ≤ 2.6
Proportion of participants with worsening disease over time following Transition Point 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
Proportion of participants with an improvement of ≥ 1.2 points in DAS-28 score from Transition Point Approximately 3 and 6 months after the transition Improvement of ≥ 1.2 points in DAS-28 score data collected
Change in the General Health Score (assessed using VAS) over time following transition point Approximately 3 and 6 months after the transition Assessed using Visual Analogue Scale (VAS) over time
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 Approximately 3 and 6 months after the transition (ASDAS-ESR ) or (CRP) score
Change in Patient Global Assessment (PtGA)-Disease activity-VAS score over time from the value obtained at the Transition Point Approximately 3 and 6 months after the transition Assessed using Disease activity-VAS score
Change in Patient Global Assessment - Visual Analogue Scale (PGA PAIN-VAS) score over time from the value obtained at the Transition Point Approximately 3 and 6 months after the transition Assessed using PAIN-VAS score
Change in Patient PGA FATIGUE -VAS score over time from the value obtained at the Transition Point Approximately 3 and 6 months after the transition Assessed using FATIGUE - VAS score
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score over time from the value obtained at the Transition Point Approximately 3 and 6 months after the transition Assessed using the HAQ-DI score
Change in PAIN-VAS score over time from the value obtained at the Transition Point Approximately 3 and 6 months after the transition Assessed using Pain - VAS score
Change in FATIGUE -VAS score over time from the value obtained at the Transition Point Approximately 3 and 6 months after the transition Assessed using FATIGUE - VAS score
Change in HAQ-DI score over time from the value obtained at the Transition Point Approximately 3 and 6 months after the transition Assessed using the HAQ-DI score
Number of Participants by Relevant Medical History At baseline and approximately 3 and 6 months after the transition Number of Participants by Demographic Category At baseline and approximately 3 and 6 months after the transition Number of Participants by Disease Status At baseline and approximately 3 and 6 months after the transition Number of Participants by Relevant Medication Use At baseline and approximately 3 and 6 months after the transition
Trial Locations
- Locations (1)
Research Site
🇩🇪München, Bavaria, Germany