Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
With
Samsung Bioepis Co., Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
