A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan)

NCT02626221 | Completed

• 1 other identifier: CIGE025EVE01
• Study Type: observational
• Target: 497
• Locations: 8 countries
• Sites: 27

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

Conditions

Chronic Urticaria

Outcome Measures

Primary Outcomes (1)

• Change in CU-Quality of Life Questionnaire Score

  The CU-QoL is a validated instrument with established psychometric properties developed specifically for the assessment of the health burden of CU. The 2013 international CU guideline recommends the use of CU-Q2oL for assessing quality of life impairment and monitoring disease activity.

  Last 15 days before each visit

Secondary Outcomes (6)

• Angioedema Quality of Life Questionnaire (AE-QoL)

  Last 4 weeks before each visit

• Change in Dermatology Life Quality Index (DLQI).

  Last 7 days before each visit

• Urticaria Activity Score for 7 days (UAS7)

  Last 7 days before each visit

• Angioedema Activity Score (AAS)

  Last 24 hours before each visit

• Urticaria Control Test (UCT)

  Last 4 weeks before each visit

Other Outcomes (9)

• Patient demographics

  At the baseline

• CU history including the method of diagnosis

  At the baseline

• The presence of angioedema at baseline and during the course of the study (incidence and number of events).

  Every 3 months, for 24 months

Study Arms (1)

Single

Single Cohort Study

Other: Non Interventional Study

Interventions

Non Interventional Study OTHER

Non Interventional Study

Single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (31)

Novartis Investigative Site

CABA, Buenos Aires, C1062ABK, Argentina

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, C1114AAJ, Argentina

Location

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, C1425BEA, Argentina

Location

Novartis Investigative Site

Lobos, Buenos Aires, Argentina

Location

Novartis Investigative Site

Buenos Aires, Nueve De Julio, B6500BWQ, Argentina

Location

Novartis Investigative Site

Rosario, Santa Fe Province, 2000, Argentina

Location

Novartis Investigative Site

Rosario, Santa Fe Province, S2000BRH, Argentina

Location

Novartis Investigative Site

Buenos Aires, C1425DKG, Argentina

Location

Novartis Investigative Site

Mendoza, M5502EZA, Argentina

Location

Novartis Investigative Site

Salta, 4400, Argentina

Location

Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

Novartis Investigative Site

Alphaville / Barueri, São Paulo, 06454-010, Brazil

Location

Novartis Investigative Site

Guarulhos, São Paulo, 07051-000, Brazil

Location

Novartis Investigative Site

Santo André, São Paulo, 09060-650, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 05437-000, Brazil

Location

Novartis Investigative Site

Medellín, Antioquia, Colombia

Location

Novartis Investigative Site

Barranquilla, Atlántico, Colombia

Location

Novartis Investigative Site

Bogotá, Cundinamarca, Colombia

Location

Novartis Investigative Site

Medellín, Colombia

Location

Novartis Investigative Site

San José, Costa Rica

Location

Novartis Investigative Site

San Rafael Escazu, Costa Rica

Location

Novartis Investigative Site

Santiago de los Caballeros, Republica Dominicana, Dominican Republic

Location

Novartis Investigative Site

Santo Domingo, Republica Dominicana, Dominican Republic

Location

Novartis Investigative Site

Santo Domingo, Dominican Republic

Location

Novartis Investigative Site

Guatemala City, 01010, Guatemala

Location

Novartis Investigative Site

San Pedro Sula, 21102, Honduras

Location

Novartis Investigative Site

San Pedro Sula, Honduras

Location

Novartis Investigative Site

Tegucigalpa, Honduras

Location

Novartis Investigative Site

Panama City, Panama

Location

Novartis Investigative Site

Jesus Maria, Lima region, 11, Peru

Location

Novartis Investigative Site

San Martín de Porres, Lima region, 31, Peru

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: December 10, 2015
• Study Start: December 24, 2014
• Primary Completion: March 21, 2018
• Study Completion: March 21, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

BR (5); AR (10); PE (2); PA (1); DO (3); CO (2); GU (1); HO (3)