Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel
Completed
- Conditions
- Rheumatoid ArthritisAxial Spondyloarthritis
- 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
- 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 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 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 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 Demographic Category At baseline and approximately 3 and 6 months after the transition Number of Participants by Relevant Medical History 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
Research Site🇩🇪München, Bavaria, Germany