A Study of Patients With Chronic Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

579 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-27

Study Completion Date

2024-11-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma Chronic Obstructive Pulmonary Disease Idiopathic Pulmonary Fibrosis IPF COPD Respiratory Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Asthma

Non-Interventional. Patients with asthma will be screened and enrolled into the active Asthma disease-specific cohort.

No interventions assigned to this group

Chronic Obstructive Pulmonary Disease (COPD)

Non-Interventional. Patients with COPD will be screened into the inactive COPD disease-specific cohort.

No interventions assigned to this group

Idiopathic Pulmonary Fibrosis (IPF)

Non-Interventional. Patients with IPF will be screened into the inactive IPF disease-specific cohort.

No interventions assigned to this group

Eligibility Criteria

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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.