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

Gamma Globulin Observations and Outcomes Database for Specific Home Infusion Evidence, Patient Care And Research Data in Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)

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.

Study Overview

• Status: Terminated
• Conditions: Primary Immune Deficiency Disorder
• Intervention / Treatment: Other: Immunoglobulin Therapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • BriovaRx Infusion Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient who is aged 7 years or greater at time of enrollment; who is on Ig therapy, have been on or is between doses of Ig therapy, or is being considered to be prescribed Ig therapy; provides informed consent for participation; and who has been determined to be eligible for infusion services by BriovaRx Infusion Services (formerly AxelaCare Health Solutions, LLC), in collaboration with the patient's prescribing physician. Subjects will be recruited from the practices of participating physicians.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immunoglobulin Therapy	Other: Immunoglobulin Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Analysis of collected data captured in CareExchange™ -ability to show and track changes in outcome data in PIDD patients.	Up to 5 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
Physician feedback will demonstrate if having real-time access to patient data captured during a home infusion will assist in the management of the patient's disease.	Up to 5 Years
Response rate for those receiving IVIg/SCIg therapies.	Up to 5 Years
Exhibit differences in response rate of IVIg/SCIg therapies across disease states and demographics	Up to 5 Years
Measure variables within patients who receive IVIg/SCIg therapies	Up to 5 Years

Collaborators and Investigators

• Sponsor: BriovaRx Infusion Services

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (ESTIMATE): June 21, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Immunology; Primary Immunodeficiency; Common Variable Immunodeficiency; Immunodeficiency; Hypogammaglobulinemia; Immune Globulin; PI; IVIg; Outcomes Research; Primary Immunodeficiency Diseases; CVID; Intravenous Immunoglobulin; PIDD; Immunodeficiencies; Subcutaneous Immunoglobulin; Acquired Hypogammaglobulinemia; Autoimmune Deficiency; SCIg
• Additional Relevant MeSH Terms: Immune System Diseases; Genetic Diseases, Inborn; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: BIS1-13-002