Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)

NCT ID: NCT01883921

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2019-08-31

Brief Summary

Primary:

• Demonstrate the utility of an electronic data capture (EDC) system (CareExchange™) using infusion nurse and patient measured physical, quality of life (QOL), respiratory, laboratory, and disability assessments in patients with Primary Immunodeficiency Disease (PIDD).

Secondary:

• Change in Intravenous/Subcutaneous Immunoglobulin (IVIg/SCIg) dose effects measured outcomes.
• Change in IVIg/SCIg dose timing effects measured outcomes.
• Change in patient status is reflected in measured outcomes.
• Assess the value to physicians from collected outcomes data.
• Identify types of patients by response to IVIg/SCIg therapies (well maintained, problematic, etc.).
• Change in response rate as measured by outcomes to IVIg/SCIg therapies by disease state, co-morbidities, and demographics.

Detailed Description

This is a prospective, observational evaluation of immunoglobulin (Ig) therapy in consenting PIDD adult and assenting pediatric subjects who receive infusion services from BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC). Subjects meeting all inclusion criteria who have provided informed consent/assent for trial participation will have validated, physician-prescribed, standard-of-care outcome measures, and Ig administration information recorded during normal home infusion visits. There will also be standard-of-care questions captured within some outcome measures recorded during normal home infusion visits that may be at a frequency and/or combination which may not be considered routine clinical care by some physicians who treat for this medical condition. Collected data will be de-identified and aggregated into cohorts of like diagnosis for trend analysis.

Conditions

Primary Immune Deficiency Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Immunoglobulin Therapy

Immunoglobulin Therapy

Intervention Type: OTHER

Interventions

Immunoglobulin Therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of any form of Primary Immunodeficiency Disease
• Age at enrollment ≥ 7
• Sign informed consent/assented to participation
• Ability to read and write English
• Understanding of study procedures and ability to comply with study procedures for the entire length of the study
• Receiving Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
• Have been on or is between doses of Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
• Being considered to be prescribed Ig under the discretion of the patient's treating physician in accordance with standard treatment practices
• Determined to be eligible for infusion services by BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC.) in collaboration with the patient's prescribing physician

Exclusion Criteria

• Children (age ≤ 6 years)
• Prisoners, and other wards of the state
• Determined to have non-competency of data collection requirements (physical assessments and use of an iPAD™) by the study participant's caregiver

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BriovaRx Infusion Services

INDUSTRY

Sponsor Role: lead

Responsible Party

Timothy P. Walton, MHS, CCRP

Timothy P. Walton, MHS, CCRP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BriovaRx Infusion Services

Lenexa, Kansas, United States

Countries

United States

Other Identifiers

BIS1-13-002

Identifier Type: -

Identifier Source: org_study_id