Description

This is a retrospective, prospective, two-way cohort study in which clinical diagnostic and treatment data will be collected on patients enrolled in the study and followed up to characterize the natural course of the patient population as systematically as possible. All treatment decisions and clinical assessments will be made by the treating physician based on conventional treatment criteria and are not required by the study design or protocol.

The purpose of this study is to examine the natural course of the disease and current treatments. An in-depth analysis of treatment regimens and treatment duration, as well as the sequence of regimen use, will be conducted to describe treatment modalities and healthcare expenditures for this disease state. No clinical device or laboratory/assessment interventions will be conducted except for disease management requirements based on routine practice requirements or treatment monitoring based on locally approved product characterization requirements. Patients will be required to complete a separate questionnaire containing basic epidemiologic information (demographics, disease history, environmental exposure history).

During the duration of this study, some patients may be enrolled in interventional clinical trials. This is allowed and expected to occur in this study. Patients will not be required to withdraw from the cohort study and will continue to be followed up as normal, unless the investigator/patient feels it is more appropriate to withdraw from the study. All requirements of the clinical trial in question are documented according to the trial protocol.