Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™)
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Purpose
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
| Condition |
|---|
|
IVIg or SCIg Therapy in the Home or at Alternate Site |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™) |
- Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Infection incidence by route, dose, and age [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Dosing information by disease type, Investigative Site, and therapeutic indication [ Time Frame: Estimated for baseline and 1 year ] [ Designated as safety issue: No ]
- Adverse events and serious adverse events by disease type and relation to Ig therapy [ Time Frame: Estimated for baseline and 1 year ] [ Designated as safety issue: Yes ]
- IVIg vs SCIg by disease type and geographic region (and/or investigative site) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Current state of disease by number of Ig doses received and overall [ Time Frame: Estimated for 1 year ] [ Designated as safety issue: No ]
- Payor type by investigator site [ Time Frame: Estimated for baseline and 1 year ] [ Designated as safety issue: No ]
- Insurance reimbursement issues [ Time Frame: Estimated for baseline and 1 year ] [ Designated as safety issue: No ]
- Concomitant medication use by disease type and therapeutic indication [ Time Frame: Estimated for baseline and 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | August 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| IVIg and SCIg 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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Contact: Sean Kearns, Ph.D | 303.672.8610 | sean.kearns@coramhc.com |
| Contact: Keith Crawford | 303.672.8705 | keith.crawford@coramhc.com |
| United States, Colorado | |
| Coram Clinical Trials | Recruiting |
| Denver, Colorado, United States, 80202 | |
| Contact: Sean Kearns, Ph.D 303-672-8610 sean.kearns@coramhc.com | |
| Contact: Keith Crawford 303.672.8705 keith.crawford@coramhc.com | |
| Principal Investigator: Luqman Seidu, MD | |
| Principal Investigator: | Luqman Seidu, MD | Unaffilated |
More Information
No publications provided
| Responsible Party: | Coram Clinical Trials |
| ClinicalTrials.gov Identifier: | NCT01109810 History of Changes |
| Other Study ID Numbers: | CT-10-02 |
| Study First Received: | April 21, 2010 |
| Last Updated: | March 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Immunoglobulins Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013