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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIg and SCIg therapy | Patients receiving Ig therapy by IV or SC route in the home or alternate site setting |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Luqman Seidu, MD | Omni Allergy, Immunology, and Asthma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coram Clinical Trials | Centennial | Colorado | 80112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 28345437 | Result | 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. | |
| Result | 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 |
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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 |