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Observe and assess the long-term use, safety and efficacy of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization. Also observe the compliance of the patients with the prescribed treatment.
This is a multi-center, uncontrolled observational study of patients who at the time of entry had moderate to severe rheumatoid arthritis (RΑ) and who were subsequently prescribed Humira (adalimumab) following normal clinical practice, with or without other anti-rheumatic treatments, prior to enrollment in this study.
These patients, at the time of entry had previously failed one or more DMARDs and had active RA despite concomitant RA treatment.
A maximum of 500 patients of either gender may be enrolled in this observational study. Patients must have been treated for at least 1 month with HUMIRA®. Patients must have been thoroughly trained in HUMIRA® injection from their physician or other health care professional. Patients may be enrolled in the PMOS a minimum of 2 weeks and a maximum of 3 months after completing 1 month of HUMIRA® treatment. A patient may only be enrolled in the PMOS once. Approximately 250 physicians will participate in the study, either in hospitals or community. The private practice physicians will be coordinated in groups of up to 30 by a hospital based rheumatologist Patients will be followed for 3 years within the post-marketing observational study. The last date for patient enrollment will be the date of enrolment of the 500th patient.The enrolment period should not exceed 18 months.
Physicians will be provided with a study kit that includes a protocol, patient informed consent forms, serious adverse event report forms, pre-addressed envelopes and Data Report Forms (DRFs) either electronically or on paper, for each patient to be enrolled. Physicians will enroll patients who have been prescribed HUMIRA® for at least one month Physicians are free to determine the appropriate therapy for each patient. The participating physician will already have provided a prescription to the patient for HUMIRA®, along with instructions for appropriate use according to the Summary of Product Characteristics (SPC) in the European Union.
Once the physician has determined that the patient meets the inclusion criteria, and the patient has agreed to be included in the observational study by signing the informed consent, the patient's Day 1 demographic data, and disease status will be reported in the Day 1 Data Report Forms. The physician will then follow-up the patient via regular office visits at intervals as determined by routine clinical practice. Patient's safety and efficacy data if they are part of clinical routine will be recorded in the Data Report Forms at Day 1, and regular visits which are closest to Month 3, Month 6, Month 9, Month 12, Month 18 , Month 24, Month 30 and Month 36. While the physician will likely deem it appropriate and necessary to have the patient return for intermediate visits during the study period, data will be collected via Data Report Forms only at the intervals which correspond closely to those described above. Physicians are encouraged to treat their patients as they would in their routine clinical practice. If treatment with adalimumab is permanently discontinued for any reason, patients will be discontinued from the study and the reason should be recorded. Physicians will be asked to record adverse events up to 3 months after last administration of adalimumab on the Data Report Form of the next scheduled data collection time.
Patients meeting all of the inclusion criteria and who have none of the exclusion criteria may be enrolled in the study.
Time Perspective: Prospective
Site Reference ID/Investigator# 29992
Active, not recruiting
Published on BioPortfolio: 2014-07-23T21:09:51-0400
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