A Study of Patients With Chronic Disease

Asthma Clinical Trial

Official title:

A Longitudinal Observational Study of Patients With Chronic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263727
• Other study ID #: TARGET-RWE
• Status: Recruiting
• Start date: February 27, 2020
• Est. completion date: February 2035

Study information

• Verified date: August 2023
• Source: Target PharmaSolutions, Inc.
• Contact: Jenna Brininger
• Phone: 757-469-2574
• Email: jbrininger[@]targetrwe.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: February 2035
• Est. primary completion date: February 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Chronic Obstructive Pulmonary Disease
• COPD
• Idiopathic Pulmonary Fibrosis
• IPF
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Fibrosis
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Locations

Country	Name	City	State
United States	University of Michigan Allergy Specialty Clinic & Food Allergy	Ann Arbor	Michigan
United States	St. Francis Medical Institute	Clearwater	Florida
United States	Asthma and Allergy Associates, PC	Colorado Springs	Colorado
United States	Family Allergy & Asthma Research Institution	Louisville	Kentucky
United States	Coastal Carolina Healthcare, P.A.	New Bern	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Target PharmaSolutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural history of chronic disease under study: Characteristics of chronic diseases under study.		Up to 10 years
Primary	Natural history of chronic disease under study: Participant demographics		Up to 10 years
Primary	Natural history of chronic disease under study: Treatment use		Up to 10 years
Primary	Natural history of chronic disease under study: Disease progression		Up to 10 years
Primary	Adverse event frequency and severity		Up to 10 years
Secondary	Natural history of chronic disease under study: Treatment response		Up to 10 years
Secondary	Time point of clinical response		Every 12 months for 10 years
Secondary	Reasons for treatment discontinuation		Up to 10 years
Secondary	Self-reported patient health measures: Asthma Control Test		Every 12 months for 10 years