Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel
NCT ID: NCT03100734
Last Updated: 2021-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
585 participants
OBSERVATIONAL
2017-06-01
2018-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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With RA
Participants with RA previously treated with Enbrel and transitioned to Benepali
Benepali
As specified in the treatment arm
Enbrel
As specified in the treatment arm
With axSpA
Participants with axSpA previously treated with Enbrel and transitioned to Benepali
Benepali
As specified in the treatment arm
Enbrel
As specified in the treatment arm
Interventions
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Benepali
As specified in the treatment arm
Enbrel
As specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Samsung Bioepis Co., Ltd.
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
München, Bavaria, Germany
Countries
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Related Links
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Manuscript description
Other Identifiers
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EUR-BNP-16-11030
Identifier Type: -
Identifier Source: org_study_id
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