A Study of Patients With Chronic Disease

Study Overview
=================
Brief Summary
-----------------
TARGET-RWE is a 10-year, international, longitudinal, observational study of patients with chronic disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. The protocol will follow a master protocol design in which a shared study infrastructure supports progressive development of the registry across the spectrum of chronic diseases.

Detailed Description
-----------------
The TARGET-RWE master protocol design allows shared study parameters and operational components to be organized within a centralized platform. Utilizing this platform, therapeutic area-aligned Communities with associated Disease-Specific Cohorts (DSC) can be added according to scientific merit and need to address specific research questions in patients diagnosed with chronic diseases. This design capitalizes on a shared, sustainable infrastructure across a diverse patient population, which allows for more efficient coordination and conduct than can be achieved in traditional stand-alone, independently-conducted research studies with narrowly-focused target patient populations. This master protocol design will ultimately support a dynamic program that adapts to the changing landscape of chronic disease management and allows for rapid enrollment and collection of retrospective and long-term prospective data from participants in specific disease areas of interest. TARGET-RWE currently includes the TARGET-RWE.LUNG Community, with open DSCs for Asthma, COPD and Idiopathic Pulmonary Fibrosis.

Official Title
-----------------
A Longitudinal Observational Study of Patients With Chronic Disease

Conditions
-----------------
Asthma, Chronic Obstructive Pulmonary Disease, Idiopathic Pulmonary Fibrosis, IPF, COPD, Respiratory Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults and children being managed or treated for a chronic disease under study. Diagnosis is based on the clinical judgement of the care provider. Patient is anticipated to have continued management of their chronic disease at the participating site. Exclusion Criteria: Inability to provide informed assent/consent.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma<br>Non-Interventional. Patients with asthma will be screened and enrolled into the active Asthma disease-specific cohort. | |
| Chronic Obstructive Pulmonary Disease (COPD)<br>Non-Interventional. Patients with COPD will be screened into the inactive COPD disease-specific cohort. | |
| Idiopathic Pulmonary Fibrosis (IPF)<br>Non-Interventional. Patients with IPF will be screened into the inactive IPF disease-specific cohort. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of chronic disease under study: Characteristics of chronic diseases under study. |  | Up to 10 years | 
| Natural history of chronic disease under study: Participant demographics |  | Up to 10 years | 
| Natural history of chronic disease under study: Treatment use |  | Up to 10 years | 
| Natural history of chronic disease under study: Disease progression |  | Up to 10 years | 
| Adverse event frequency and severity |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of chronic disease under study: Treatment response |  | Up to 10 years | 
| Time point of clinical response |  | Every 12 months for 10 years | 
| Reasons for treatment discontinuation |  | Up to 10 years | 
| Self-reported patient health measures: Asthma Control Test |  | Every 12 months for 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IPF, COPD, Respiratory Disease, Asthma