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

Coram Clinical Trials

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01109810

CT-10-02

Details and patient eligibility

About

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

Full 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

Enrollment: 496 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

496 participants in 1 patient group

IVIg and SCIg therapy

Description:

Patients receiving Ig therapy by IV or SC route in the home or alternate site setting