Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™) (IDEaL)

The IDEaL registry is a cooperative, observational registry focused on immunoglobulin use in the U.S. The registry is a deliberate and purposeful assembly of clinical and humanistic knowledge that is intended to act as a longitudinal database, tracking outcomes of routine clinical practice.

The central goal of the registry is to provide a mechanism that allows for a better understanding of how immunoglobulin therapy is being used in a real-world clinical setting. The data gathered will help the industry gain a better understanding surrounding the therapeutic value of immunoglobulin therapy and subsequently improve practices, reduce medical costs, and ultimately improve the clinical outcomes for the patients receiving immunoglobulin therapy

Study Overview

• Status: Completed
• Conditions: IVIg or SCIg Therapy in the Home or at Alternate Site

Detailed Description

The registry's goal is to significantly contribute to the medical understanding of Ig therapy and to improve the quality of care for patients receiving Ig therapy in the United States through active publication of registry findings and disease management approaches.

The IDEaL program represents a unique and powerful method for the collection of:

Patient Level / Humanistic Data / Quality of Life Physician Level / Practice Patterns Clinical Data / Therapeutic Outcomes Reimbursement / Impact on Treatment / Policy Decisions

Whereby:

Accelerating innovation Producing faster knowledge gains Improving awareness of patient outcomes and disease burden Providing a clearer understanding of therapy impact on patients' quality of life.

The objectives of the Registry are:

to enhance the understanding of the variability, progression, and natural history of disease requiring Ig therapy with the ultimate goal of better guiding and assessing therapeutic intervention; to provide the Ig medical community with recommendations for monitoring patients and to provide reports on patient outcomes to help optimize patient care; and to serve as an active knowledge base that can provide population-management information, which can be used to generate patient-management and practice-management tools; and

• Study Type: Observational
• Enrollment (Actual): 496

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Coram Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The IDEaL Registry program will collect data representative of patients receiving Ig therapy (IVIg and SCIg) in a homecare setting and/or through Coram's ambulatory infusion suites.

Description

Inclusion Criteria:

• Signed informed consent
• Any age, disease, or gender requiring Ig therapy
• Agree to the use of Coram's infusion services after entry into IDEaL Registry

Exclusion Criteria:

• Unable to start, or stops taking Ig therapy
• Use of an insurance provider for which Coram's services are not covered/authorized.
• Have previously participated in the IDEaL Registry and revoked consent to use their PHI

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
IVIg and SCIg therapy; Patients receiving Ig therapy by IV or SC route in the home or alternate site setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic)	Recorded from referral form	Baseline
Infection incidence by route, dose, and age	Infection incidence, route, dose recorded from Clinical Progress reports Immune Replacement Efficacy section	every 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosing information by disease type, Investigative Site, and therapeutic indication	Dosing collected from Clinical Progress Reports and/or Medication Record	Estimated for baseline and 1 year
Adverse events and serious adverse events by disease type and relation to Ig therapy	Collected from Clinical Progress Reports Therapy Tolerance section	Estimated for baseline and 1 year
IVIg vs SCIg by disease type and geographic region (and/or investigative site)	Route collected from Clinical Progress Reports and/or Medication Record	Baseline
Current state of disease by number of Ig doses received and overall	Ig doses monitored by missed dose section of Clinical Progress Report and Shipping Records	Estimated for 1 year
Payor type by investigator site	Recorded from referral information	Estimated for baseline and 1 year
Insurance reimbursement issues	Obtained when patient has to discharge from study due to insurance change and Coram not a provider	Estimated for baseline and 1 year
Concomitant medication use by disease type and therapeutic indication	Collected from Medication Record	Estimated for baseline and 1 year

Collaborators and Investigators

• Sponsor: Coram Clinical Trials
• Investigators: Principal Investigator: Luqman Seidu, MD, Omni Allergy, Immunology, and Asthma

Publications and helpful links

General Publications

• IMMUNOGLOBULIN THERAPY AND QUALITY OF LIFE IN PRIMARY IMMUNODEFICIENCY PATIENTS WITH NON-INFECTIOUS PULMONARY COMPLICATIONS Checkley, A. et al. Annals of Allergy, Asthma & Immunology , Volume 121 , Issue 5 , S9 - S10
• Kearns S, Kristofek L, Bolgar W, Seidu L, Kile S. Clinical Profile, Dosing, and Quality-of-Life Outcomes in Primary Immune Deficiency Patients Treated at Home with Immunoglobulin G: Data from the IDEaL Patient Registry. J Manag Care Spec Pharm. 2017 Apr;23(4):400-406. doi: 10.18553/jmcp.2017.23.4.400.
• P259 Optimizing subcutaneous dosing of immunoglobulin in obese primary immune deficiency patients treated in the home Checkley, A. et al. Annals of Allergy, Asthma & Immunology , Volume 119 , Issue 5 , S65

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2010
• Primary Completion (ACTUAL): June 10, 2022
• Study Completion (ACTUAL): June 10, 2022

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (ESTIMATE): April 23, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CT-10-02