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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02626221
• Collaborator: (none)
• Enrollment: 497
• Locations: 31
• Actual Duration (Months): 38.9
• Patients Per Site: 16
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Urticaria	Other: Non Interventional Study

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 497 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Dec 24, 2014
• Actual Primary Completion Date: Mar 21, 2018
• Actual Study Completion Date: Mar 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Single Single Cohort Study	Other: Non Interventional Study; Non Interventional Study

Outcome Measures

Primary Outcome Measures

1. Change in CU-Quality of Life Questionnaire Score [Last 15 days before each visit]

   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.

Secondary Outcome Measures

1. Angioedema Quality of Life Questionnaire (AE-QoL) [Last 4 weeks before each visit]

   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)

2. Change in Dermatology Life Quality Index (DLQI). [Last 7 days before each visit]

   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

3. Urticaria Activity Score for 7 days (UAS7) [Last 7 days before each visit]

   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

4. Angioedema Activity Score (AAS) [Last 24 hours before each visit]

   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.

5. Urticaria Control Test (UCT) [Last 4 weeks before each visit]

   Short questionnaire assessing how well the urticaria symptoms were controlled over the last 4 weeks

6. 6-item Work Productivity and Activity Impairment (WPAI) instrument [Last 7 days before each visit]

   Respondents are asked questions about work and activity impairment due to health problems

Other Outcome Measures

1. Patient demographics [At the baseline]

   Information like: (age, gender) and physical characteristics (height, weight).

2. CU history including the method of diagnosis [At the baseline]

   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.

3. The presence of angioedema at baseline and during the course of the study (incidence and number of events). [Every 3 months, for 24 months]

   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

4. Previous and concomitant CU treatments including treatment adjustments during the course of the study. [Every 3 months, for 24 months]

   Concomitant medications

5. Patient-reported use of CU-related health care resources [Every 3 months, for 24 months]

   Including hospitalizations (frequency and duration), emergency room visits (frequency), planned and unplanned visits to a physician (frequency), and phone calls.

6. Incidence of spontaneous disease remission and the time to spontaneous remission [Every 3 months, for 24 months]

   As per physician judgment

7. Proportion of patients responding to each class of therapy [Every 3 months, for 24 months]

   As per physician judgment

8. Changes in the type of CU (spontaneous, inducible, or both) and the types of inducible urticaria [Every 3 months, for 24 months]

   As per physician judgment

9. Patient satisfaction with treatment as assessed on a simple 0-10 VAS scale [Every 3 months, for 24 months]

   simple VAS scale where '0' corresponds to poorly satisfy and '10' corresponds to highly satisfy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Caba	Buenos Aires	Argentina	C1062ABK
2	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires	Argentina	C1114AAJ
3	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires	Argentina	C1425BEA
4	Novartis Investigative Site	Lobos	Buenos Aires	Argentina
5	Novartis Investigative Site	Buenos Aires	Nueve De Julio	Argentina	B6500BWQ
6	Novartis Investigative Site	Rosario	Santa Fe	Argentina	2000
7	Novartis Investigative Site	Rosario	Santa Fe	Argentina	S2000BRH
8	Novartis Investigative Site	Buenos Aires		Argentina	C1425DKG
9	Novartis Investigative Site	Mendoza		Argentina	M5502EZA
10	Novartis Investigative Site	Salta		Argentina	4400
11	Novartis Investigative Site	Rio de Janeiro	RJ	Brazil	21941-913
12	Novartis Investigative Site	Alphaville / Barueri	Sao Paulo	Brazil	06454-010
13	Novartis Investigative Site	Guarulhos	SP	Brazil	07051-000
14	Novartis Investigative Site	Santo Andre	SP	Brazil	09060-650
15	Novartis Investigative Site	Sao Paulo	SP	Brazil	05437-000
16	Novartis Investigative Site	Medellin	Antioquia	Colombia
17	Novartis Investigative Site	Barranquilla	Atlantico	Colombia
18	Novartis Investigative Site	Bogotá	Cundinamarca	Colombia
19	Novartis Investigative Site	Medellín		Colombia
20	Novartis Investigative Site	San José		Costa Rica
21	Novartis Investigative Site	San Rafael Escazu		Costa Rica
22	Novartis Investigative Site	Santiago	Republica Dominicana	Dominican Republic
23	Novartis Investigative Site	Santo Domingo	Republica Dominicana	Dominican Republic
24	Novartis Investigative Site	Santo Domingo		Dominican Republic
25	Novartis Investigative Site	Guatemala City		Guatemala	01010
26	Novartis Investigative Site	San Pedro Sula		Honduras	21102
27	Novartis Investigative Site	San Pedro Sula		Honduras
28	Novartis Investigative Site	Tegucigalpa		Honduras
29	Novartis Investigative Site	Panama		Panama
30	Novartis Investigative Site	Jesus Maria	Lima	Peru	11
31	Novartis Investigative Site	San Martin de Porres	Lima	Peru	31

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02626221
• Other Study ID Numbers: CIGE025EVE01
• First Posted: Dec 10, 2015
• Last Update Posted: Dec 7, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Urticaria; Chronic Urticaria

Study Results

No Results Posted as of Dec 7, 2018