Chronic Urticaria Clinical Trial
Official title:
A Prospective Non-interventional Study to Collect Real Life Clinical Data on the Impact of Therapy, the Diagnosis and Management of Chronic Urticaria in Patients Refractory to at Least One Course of H1 Antihistamine Therapy
This is a non-interventional, multi-country, Latin American study utilizing a prospective
single-cohort design. Eligible CU patients will be enrolled in the study and will be followed
for 24 months (± 6 weeks).
In accordance with the observational nature of the study, there will be no interventions or
interference with the routine care of the patient which will be based solely on the clinical
judgment of the treating physician. However, with respect to the frequency and schedule of
assessments, the schedule included in Table 7-1 will be recommended.
The selection of the treatment for CU will be clearly separated from the decision to include
the patient in the study, and will be made at the discretion of the treating physician in
accordance with standard medical practice, the investigator's clinical judgment, and global
urticarial guidelines.
In order to prevent selection bias, investigators should offer enrollment to all consecutive
patients meeting study criteria, likely to be available for the full duration of the
follow-up period of 24 months, and willing to participate in the study.
The overall objective of the study is to evaluate in real-life the CU disease burden, the
current treatment patterns and the use of health care resources in patients refractory to
H1-antihistamine treatment
n/a
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