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Trial record 39 of 158 for:    Diseases | ( Map: Costa Rica )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02626221
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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
Chronic Urticaria Other: Non Interventional Study

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Study Type : Observational [Patient Registry]
Actual Enrollment : 497 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
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 : December 24, 2014
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : March 21, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Single
Single Cohort Study
Other: Non Interventional Study
Non Interventional Study




Primary Outcome Measures :
  1. Change in CU-Quality of Life Questionnaire Score [ Time Frame: 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) [ Time Frame: 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). [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At the baseline ]
    Information like: (age, gender) and physical characteristics (height, weight).

  2. CU history including the method of diagnosis [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: Every 3 months, for 24 months ]
    Concomitant medications

  5. Patient-reported use of CU-related health care resources [ Time Frame: 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 [ Time Frame: Every 3 months, for 24 months ]
    As per physician judgment

  7. Proportion of patients responding to each class of therapy [ Time Frame: 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 [ Time Frame: Every 3 months, for 24 months ]
    As per physician judgment

  9. Patient satisfaction with treatment as assessed on a simple 0-10 VAS scale [ Time Frame: Every 3 months, for 24 months ]
    simple VAS scale where '0' corresponds to poorly satisfy and '10' corresponds to highly satisfy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626221


Locations
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Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1062ABK
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1114AAJ
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, Argentina, C1425BEA
Novartis Investigative Site
Lobos, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Nueve De Julio, Argentina, B6500BWQ
Novartis Investigative Site
Rosario, Santa Fe, Argentina, 2000
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000BRH
Novartis Investigative Site
Buenos Aires, Argentina, C1425DKG
Novartis Investigative Site
Mendoza, Argentina, M5502EZA
Novartis Investigative Site
Salta, Argentina, 4400
Brazil
Novartis Investigative Site
Rio de Janeiro, RJ, Brazil, 21941-913
Novartis Investigative Site
Alphaville / Barueri, Sao Paulo, Brazil, 06454-010
Novartis Investigative Site
Guarulhos, SP, Brazil, 07051-000
Novartis Investigative Site
Santo Andre, SP, Brazil, 09060-650
Novartis Investigative Site
Sao Paulo, SP, Brazil, 05437-000
Colombia
Novartis Investigative Site
Medellin, Antioquia, Colombia
Novartis Investigative Site
Barranquilla, Atlantico, Colombia
Novartis Investigative Site
Bogotá, Cundinamarca, Colombia
Novartis Investigative Site
Medellín, Colombia
Costa Rica
Novartis Investigative Site
San José, Costa Rica
Novartis Investigative Site
San Rafael Escazu, Costa Rica
Dominican Republic
Novartis Investigative Site
Santiago, Republica Dominicana, Dominican Republic
Novartis Investigative Site
Santo Domingo, Republica Dominicana, Dominican Republic
Novartis Investigative Site
Santo Domingo, Dominican Republic
Guatemala
Novartis Investigative Site
Guatemala City, Guatemala, 01010
Honduras
Novartis Investigative Site
San Pedro Sula, Honduras, 21102
Novartis Investigative Site
San Pedro Sula, Honduras
Novartis Investigative Site
Tegucigalpa, Honduras
Panama
Novartis Investigative Site
Panama, Panama
Peru
Novartis Investigative Site
Jesus Maria, Lima, Peru, 11
Novartis Investigative Site
San Martin de Porres, Lima, Peru, 31
Sponsors and Collaborators
Novartis Pharmaceuticals

Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02626221     History of Changes
Other Study ID Numbers: CIGE025EVE01
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Additional relevant MeSH terms:
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Skin Diseases, Vascular
Skin Diseases
Immune System Diseases
Urticaria
Hypersensitivity, Immediate
Hypersensitivity
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs