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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.
The primary objective of this post-marketing observational study (PMOS) is to evaluate the clinical outcome of HUMIRA® in routine clinical use in rheumatologic patients in different Eastern European countries.
The secondary objectives of this PMOS are to evaluate in rheumatologic patients being routinely treated with Humira in Eastern Europe:
- Tolerability of treatment with HUMIRA®
- Duration of treatment with HUMIRA ®
- Change in Quality of Life (HAQ-DI)
- Patient acceptability of self-injection and compliance with therapy
- Patient characteristics (demographic, social, disease type, severity and duration)
- The routine rheumatologic practices (previous and current disease specific treatment) Each patient will be observed during his/her HUMIRA® treatment for a period of max. 13 months.
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.
The tuberculosis (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.
Study Conduct This PMOS will be conducted in a prospective, single-arm, multicountry, multicenter format.
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 TB screening and prophylaxis, if indicated), which defines the survey for each patient.
For indicative purposes, follow-up of patients should enable 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 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.
For these reasons, the most likely visits are defined as "V1", "V2", "V3", "V4", "V5", "V6", "V7", although numbers and dates will depend only on the decision of the physician:
- V1: Screening visit (followed by TB prophylaxis, if indicated)
- V2: Baseline and introduction of HUMIRA® therapy
- V3: 1 month after introduction of HUMIRA® therapy
- V4: 3 months after previous visit
- V5: 3 months after previous visit
- V6: 3 months after previous visit
- V7: 3 months after previous visit Failure to meet these suggested dates will not constitute a breach of the protocol.
Time Perspective: Prospective
Site Reference ID/Investigator# 32631
Published on BioPortfolio: 2014-07-23T21:09:57-0400
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