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

• ClinicalTrials.gov Identifier: NCT01883921
• Recruitment Status: Terminated
• First Posted: June 21, 2013
• Last Update Posted: August 7, 2019
• Sponsor: BriovaRx Infusion Services
• Information provided by (Responsible Party): Timothy P. Walton, MHS, CCRP, BriovaRx Infusion Services

Study Description

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.

Condition or disease	Intervention/treatment
Primary Immune Deficiency Disorder	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 Design

• Study Type: Observational
• Estimated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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)
• Study Start Date: June 2013
• Actual Primary Completion Date: August 2019
• Actual Study Completion Date: August 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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. [ Time Frame: Up to 5 Years ]
2. Response rate for those receiving IVIg/SCIg therapies. [ Time Frame: Up to 5 Years ]
3. Exhibit differences in response rate of IVIg/SCIg therapies across disease states and demographics [ Time Frame: Up to 5 Years ]
4. Measure variables within patients who receive IVIg/SCIg therapies [ Time Frame: Up to 5 Years ]

Eligibility Criteria

• Ages Eligible for Study: 7 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, Kansas

BriovaRx Infusion Services

Lenexa, Kansas, United States, 66219

Sponsors and Collaborators

BriovaRx Infusion Services

More Information

• Responsible Party: Timothy P. Walton, MHS, CCRP, BriovaRx Infusion Services
• ClinicalTrials.gov Identifier: NCT01883921
• Other Study ID Numbers: BIS1-13-002
• First Posted: June 21, 2013
• Last Update Posted: August 7, 2019
• Last Verified: August 2019

Keywords provided by Timothy P. Walton, MHS, CCRP, BriovaRx Infusion Services:

Primary Immunodeficiency; Immunodeficiencies; Primary Immunodeficiency Diseases; Common Variable Immunodeficiency; Immunodeficiency; PIDD; CVID; PI; Hypogammaglobulinemia; Acquired Hypogammaglobulinemia; Immunology; Autoimmune Deficiency; Intravenous Immunoglobulin; Subcutaneous Immunoglobulin; IVIg; SCIg; Immune Globulin; Outcomes Research

Additional relevant MeSH terms:

Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Genetic Diseases, Inborn; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; Immunologic Factors; Physiological Effects of Drugs