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

Chronic Urticaria Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626221
• Other study ID #: CIGE025EVE01
• Status: Completed
• Start date: December 24, 2014
• Est. completion date: March 21, 2018

Study information

• Verified date: December 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria

Intervention

Other:
• Non Interventional Study
Non Interventional Study

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires	Nueve De Julio
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	Lobos	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Salta
Brazil	Novartis Investigative Site	Alphaville / Barueri	Sao Paulo
Brazil	Novartis Investigative Site	Guarulhos	SP
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	Santo Andre	SP
Brazil	Novartis Investigative Site	Sao Paulo	SP
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Bogotá	Cundinamarca
Colombia	Novartis Investigative Site	Medellin	Antioquia
Colombia	Novartis Investigative Site	Medellín
Costa Rica	Novartis Investigative Site	San José
Costa Rica	Novartis Investigative Site	San Rafael Escazu
Dominican Republic	Novartis Investigative Site	Santiago	Republica Dominicana
Dominican Republic	Novartis Investigative Site	Santo Domingo	Republica Dominicana
Dominican Republic	Novartis Investigative Site	Santo Domingo
Guatemala	Novartis Investigative Site	Guatemala City
Honduras	Novartis Investigative Site	San Pedro Sula
Honduras	Novartis Investigative Site	San Pedro Sula
Honduras	Novartis Investigative Site	Tegucigalpa
Panama	Novartis Investigative Site	Panama
Peru	Novartis Investigative Site	Jesus Maria	Lima
Peru	Novartis Investigative Site	San Martin de Porres	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Brazil,  Colombia,  Costa Rica,  Dominican Republic,  Guatemala,  Honduras,  Panama,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient demographics	Information like: (age, gender) and physical characteristics (height, weight).	At the baseline
Other	CU history including the method of diagnosis	Including diagnostic aids/tools used, ASST results), the time of onset of CU, the CU type (spontaneous, inducible or both), and the prevalence of inducible types of urticaria (e.g. cold, heat, light, aquagenic, cholinergic, contact), if applicable.	At the baseline
Other	The presence of angioedema at baseline and during the course of the study (incidence and number of events).	Angioedema is typically characterized by: 1.-Sudden, pronounced swelling of the lower dermis and subcutis. 2.-Sometimes pain rather than itching. 3.-Frequent involvement below mucous membranes. 4.-Up to 72 hours for resolution	Every 3 months, for 24 months
Other	Previous and concomitant CU treatments including treatment adjustments during the course of the study.	Concomitant medications	Every 3 months, for 24 months
Other	Patient-reported use of CU-related health care resources	Including hospitalizations (frequency and duration), emergency room visits (frequency), planned and unplanned visits to a physician (frequency), and phone calls.	Every 3 months, for 24 months
Other	Incidence of spontaneous disease remission and the time to spontaneous remission	As per physician judgment	Every 3 months, for 24 months
Other	Proportion of patients responding to each class of therapy	As per physician judgment	Every 3 months, for 24 months
Other	Changes in the type of CU (spontaneous, inducible, or both) and the types of inducible urticaria	As per physician judgment	Every 3 months, for 24 months
Other	Patient satisfaction with treatment as assessed on a simple 0-10 VAS scale	simple VAS scale where '0' corresponds to poorly satisfy and '10' corresponds to highly satisfy	Every 3 months, for 24 months
Primary	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	Angioedema Quality of Life Questionnaire (AE-QoL)	For patients with angioedema, the symptom-specific quality of life will be assessed over the course of the study with the Angioedema Quality of Life Questionnaire (AE-QoL)	Last 4 weeks before each visit
Secondary	Change in Dermatology Life Quality Index (DLQI).	A 10-item dermatology-specific health-related quality-of-life measure assessing dermatology symptoms and their impact on various aspects of life, during the course of the study	Last 7 days before each visit
Secondary	Urticaria Activity Score for 7 days (UAS7)	Patients willing and able to comply with the UAS7 assessment will be given a paper-based urticaria diary at every site visit and be asked to complete it daily over the week preceding the next site visit. The diary consists of questions to evaluate the severity of their disease, and patients have to assess the severity of their disease, numbers of wheals and severity of itching	Last 7 days before each visit
Secondary	Angioedema Activity Score (AAS)	The Angioedema Activitiy Score (AAS) is a validated, easy to use tool to determine disease activity in patients with recurrent angioedema, independent of its underlying causes. The AAS is designed to be used by patients for their daily documentation of swelling episodes including their duration, severity and impact on daily functioning and appearance.	Last 24 hours before each visit
Secondary	Urticaria Control Test (UCT)	Short questionnaire assessing how well the urticaria symptoms were controlled over the last 4 weeks	Last 4 weeks before each visit
Secondary	6-item Work Productivity and Activity Impairment (WPAI) instrument	Respondents are asked questions about work and activity impairment due to health problems	Last 7 days before each visit