Overview

This trial is active, not recruiting.

Condition chronic urticaria
Treatment non interventional study
Sponsor Novartis Pharmaceuticals
Start date December 2014
End date March 2018
Trial size 494 participants
Trial identifier NCT02626221, CIGE025EVE01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Single Cohort Study
non interventional study
Non Interventional Study

Primary Outcomes

Measure
Change in CU-Quality of Life Questionnaire Score
time frame: Last 15 days before each visit

Secondary Outcomes

Measure
Angioedema Quality of Life Questionnaire (AE-QoL)
time frame: Last 4 weeks before each visit
Change in Dermatology Life Quality Index (DLQI).
time frame: Last 7 days before each visit
Urticaria Activity Score for 7 days (UAS7)
time frame: Last 7 days before each visit
Angioedema Activity Score (AAS)
time frame: Last 24 hours before each visit
Urticaria Control Test (UCT)
time frame: Last 4 weeks before each visit
6-item Work Productivity and Activity Impairment (WPAI) instrument
time frame: Last 7 days before each visit

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Men or Women at least 18 years of age or older. Patient has medically confirmed diagnosis of chronic urticaria present for more than 2 months. Patient has been treated with at least one course of H1 antihistamines and is refractory to this treatment Patient has provided written informed consent allowing the use of their anonymous data for the purposes of the study Exclusion Criteria: Patient is currently participating in a clinical trial. Patient is, in the opinion of the treating physician, unlikely to be available for the full duration of the follow-up period of 24 months

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Novartis.