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

Completed

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

• Registration Number: NCT01109810
• Lead Sponsor: Coram Clinical Trials

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

Study Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2010-09-08
• Status Verified: 2022-06
• Primary Completion: 2022-06-10
• Study Completion: 2022-06-10
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 496

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Coram Clinical Trials; 🇺🇸 Centennial, Colorado, United States