Clinical trial NCT02626221: A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Urticaria
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-12-10
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible Latin American Chronic Urticaria adult patients, males and females, with at least one course of H1 antihistamines and is shown to be refractory to this treatment

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Change in CU-Quality of Life Questionnaire Score
timeFrame: Last 15 days before each visit
Secondary outcomes:
measure: Angioedema Quality of Life Questionnaire (AE-QoL)
timeFrame: Last 4 weeks before each visit
measure: Change in Dermatology Life Quality Index (DLQI).
timeFrame: Last 7 days before each visit
measure: Urticaria Activity Score for 7 days (UAS7)
timeFrame: Last 7 days before each visit
measure: Angioedema Activity Score (AAS)
timeFrame: Last 24 hours before each visit
measure: Urticaria Control Test (UCT)
timeFrame: Last 4 weeks before each visit
measure: 6-item Work Productivity and Activity Impairment (WPAI) instrument
timeFrame: Last 7 days before each visit
Other outcomes:
measure: Patient demographics
timeFrame: At the baseline
measure: CU history including the method of diagnosis
timeFrame: At the baseline
measure: The presence of angioedema at baseline and during the course of the study (incidence and number of events).
timeFrame: Every 3 months, for 24 months
measure: Previous and concomitant CU treatments including treatment adjustments during the course of the study.
timeFrame: Every 3 months, for 24 months
measure: Patient-reported use of CU-related health care resources
timeFrame: Every 3 months, for 24 months
measure: Incidence of spontaneous disease remission and the time to spontaneous remission
timeFrame: Every 3 months, for 24 months
measure: Proportion of patients responding to each class of therapy
timeFrame: Every 3 months, for 24 months
measure: Changes in the type of CU (spontaneous, inducible, or both) and the types of inducible urticaria
timeFrame: Every 3 months, for 24 months
measure: Patient satisfaction with treatment as assessed on a simple 0-10 VAS scale
timeFrame: Every 3 months, for 24 months
Locations:
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Lobos
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
state: Nueve De Julio
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Salta
country: Argentina
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Alphaville / Barueri
country: Brazil
facility: Novartis Investigative Site
state: Sao Paulo
city: Guarulhos
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Santo Andre
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Medellin
country: Colombia
facility: Novartis Investigative Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
state: Atlantico
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Medellín
country: Colombia
facility: Novartis Investigative Site
city: San José
country: Costa Rica
facility: Novartis Investigative Site
city: San Rafael Escazu
country: Costa Rica
facility: Novartis Investigative Site
city: Santiago
country: Dominican Republic
facility: Novartis Investigative Site
state: Republica Dominicana
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
state: Republica Dominicana
city: Santo Domingo
country: Dominican Republic
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigative Site
city: San Pedro Sula
country: Honduras
facility: Novartis Investigative Site
city: San Pedro Sula
country: Honduras
facility: Novartis Investigative Site
city: Tegucigalpa
country: Honduras
facility: Novartis Investigative Site
city: Panama
country: Panama
facility: Novartis Investigative Site
city: Jesus Maria
country: Peru
facility: Novartis Investigative Site
state: Lima
city: San Martin de Porres
country: Peru
facility: Novartis Investigative Site
state: Lima
Study officials:
References: