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

NCT01883921 | Terminated

• 1 other identifier: BIS1-13-002
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Immune Deficiency Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Analysis of collected data captured in CareExchange™ -ability to show and track changes in outcome data in PIDD patients.

  Up to 5 Years

Secondary Outcomes (4)

• 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

Study Arms (1)

Immunoglobulin Therapy

Other: Immunoglobulin Therapy

Interventions

Immunoglobulin Therapy OTHER

Immunoglobulin Therapy

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BriovaRx Infusion Services: lead

Study Sites (1)

BriovaRx Infusion Services

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency; Agammaglobulinemia

Interventions

Immunization, Passive

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immune System Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Timothy P. Walton, MHS, CCRP

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (1)