Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
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ClinicalTrials.gov Identifier: NCT01883921
Recruitment Status :
First Posted : June 21, 2013
Last Update Posted : August 7, 2019
BriovaRx Infusion Services
Information provided by (Responsible Party):
Timothy P. Walton, MHS, CCRP, BriovaRx Infusion Services
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).
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
Primary Immune Deficiency Disorder
Other: Immunoglobulin Therapy
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.
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Layout table for eligibility information
Ages Eligible for Study:
7 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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