Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT03100734
Eligibility Criteria:
Key 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03100734
Study Brief:
Protocol Section:
NCT03100734