EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries (EviraEAST)
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About
This is a non-interventional, post-marketing, observational study (PMOS) in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exists to characterize patient populations being prescribed Humira in Eastern Europe. Further, it is important to establish the clinical outcome and tolerability of Humira in Eastern European patients, as well as their compliance with Humira treatment, in particular the acceptability of self-injection, which may influence all of the above in routine clinical practice.
Full description
This PMOS will be conducted in a prospective, single-arm, multicountry, multicenter format. The assignment of the patient to Humira is not decided in advance by this protocol but falls within the current practice. The prescription of Humira is clearly separated from the decision to include the patient in this study. No additional procedures (other than standard of care) shall be applied to the patients. As this study is observational in nature, its follow-up is not interventional and is left to the judgment of each physician within the 14-17 months period (including tuberculosis (TB) screening and prophylaxis, if indicated), which defines the survey for each patient. The TB screening period per patient will be 1-4 weeks and, if applicable, the TB prophylactic treatment period before Humira administration will be 1 month in accordance with local guidelines. For indicative purposes, follow-up of patients should entail approximately 7 patient visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following TB screening. The first visit following introduction of Humira and final visits are required because of intercurrent events. If treatment with Humira is discontinued, the standard practice is to review the patient after a period of 70 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. If the physician decides to permanently discontinue Humira before the end of the planned observational period of 13 months, the reason for discontinuation and the new treatment regimen prescribed, if applicable, will be documented. The next routine follow-up visit will be the termination visit for this patient in the PMOS.
Enrollment
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Inclusion criteria
- Adult patients with active RA, PsA or AS for whom Humira therapy is indicated according to the local product label and who meet the following criteria:
- Are newly prescribed Humira therapy (no prior history of treatment with Humira), including patients with infliximab or etanercept treatment history OR
- Completed Abbott sponsored interventional clinical trials and are continuing treatment with commercial Humira thereafter.
Exclusion criteria
- Patients who are being treated or will be treated with drugs at risk of interactions with Humira (see Humira Summary of Product Characteristics)
- Patients currently participating in another clinical trial
- Patients with diagnosis of active tuberculosis
Trial design
809 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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