Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting

Condition(s) targeted: Primary Immunodeficiency Disease (PIDD)

Phase: N/A

Status: Recruiting

Sponsored by: AxelaCare Health Solutions, LLC

The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and disability assessments using CareExchange in the home setting.

Official title: Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Analysis of collected data captured in CareExchange will demonstrate the ability to show and track changes in outcome data in 5% treatment naïve IVIg PIDD patients in the home setting.

Secondary outcome:

Evaluate the profile physician usage (dose and timing) with Gammaplex®.

Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions.

Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting.

Demonstration of response rate for those receiving IVIg therapies.

Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation.

Demonstration of measured variables within patients who receive IVIg therapies.

Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes.

Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.).

Minimum age: 15 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of any form of Primary Immunodeficiency Disease

- Males and Females

- ≥ 15 and ≤ 85 years of age

- 5% treatment Naïve IVIg for the treatment of PIDD

- Ability to have Gammaplex® IVIg prescribed under the discretion of the patient's

treating physician in accordance with standard treatment practices for the entire duration of the study

- Ability and willingness to provide informed consent and comply with study

requirements and procedures

- Ability to read and write English

- Understanding of study procedures and ability to comply with study procedures for the

entire length of the study

- Eligible for infusion services by AxelaCare Health Solutions, LLC, in collaboration

with the subject's prescribing physician and insurance provider Exclusion Criteria:

- The presence of any medical condition that the investigator and/or prescribing

physician deems incompatible with participation in this trial.

- Prisoners, and other wards of the state

- Determined to have non-competency of data collection requirements (physical

assessments and use of an iPADâ„¢) by either the home infusion nurse and/or Caregiver.

- Receiving Subcutaneous Immunoglobulin (SCIg) Therapy during study participation.

IMMUNEOe International Research Centers, Centennial, Colorado 80122, United States; Recruiting
Maninderpal Singh Sethi, Phone: 303-771-9000, Ext: 1234, Email: msethi@immunoeresearch.com
James Benedetto, Phone: 303-771-9000, Ext: 1221, Email: jbenedetto@immunoeresearch.com
Isaac Melamed, MD, Principal Investigator

Atlanta ENT, Atlanta, Georgia 30342, United States; Recruiting
Latika Burt, Phone: 404-255-2918, Email: lburt@atlantaent.com
Merin Kuruvilla, MD, Principal Investigator

AxelaCare Health Solutions, LLC, Lenexa, Kansas 66219, United States; Recruiting
Timothy Walton, MHS, CCRP, Phone: 877-342-9352, Email: twalton@axelacare.com

Starting date: June 2014
Last updated: July 27, 2015