Clinical trial NCT01109810: Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™)
Official title: Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IVIg or SCIg Therapy in the Home or at Alternate Site
Lead sponsor: Coram Clinical Trials
Sponsor class: OTHER
First posted: 2010-04-23
Enrollment: 496
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic)
timeFrame: Baseline
measure: Infection incidence by route, dose, and age
timeFrame: every 6 months
Secondary outcomes:
measure: Dosing information by disease type, Investigative Site, and therapeutic indication
timeFrame: Estimated for baseline and 1 year
measure: Adverse events and serious adverse events by disease type and relation to Ig therapy
timeFrame: Estimated for baseline and 1 year
measure: IVIg vs SCIg by disease type and geographic region (and/or investigative site)
timeFrame: Baseline
measure: Current state of disease by number of Ig doses received and overall
timeFrame: Estimated for 1 year
measure: Payor type by investigator site
timeFrame: Estimated for baseline and 1 year
measure: Insurance reimbursement issues
timeFrame: Estimated for baseline and 1 year
measure: Concomitant medication use by disease type and therapeutic indication
timeFrame: Estimated for baseline and 1 year
Other outcomes:
Locations:
city: Centennial
country: United States
facility: Coram Clinical Trials
state: Colorado
Study officials:
affiliation: Omni Allergy, Immunology, and Asthma
name: Luqman Seidu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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