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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01109810
Recruitment Status : Recruiting
First Posted : April 23, 2010
Last Update Posted : May 14, 2018
Information provided by (Responsible Party):
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

Condition or disease
IVIg or SCIg Therapy in the Home or at Alternate Site

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


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 Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™)
Study Start Date : August 2010
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2025

IVIg and SCIg therapy

Primary Outcome Measures :
  1. Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic) [ Time Frame: Baseline ]
  2. Infection incidence by route, dose, and age [ Time Frame: every 6 months ]

Secondary Outcome Measures :
  1. Dosing information by disease type, Investigative Site, and therapeutic indication [ Time Frame: Estimated for baseline and 1 year ]
  2. Adverse events and serious adverse events by disease type and relation to Ig therapy [ Time Frame: Estimated for baseline and 1 year ]
  3. IVIg vs SCIg by disease type and geographic region (and/or investigative site) [ Time Frame: Baseline ]
  4. Current state of disease by number of Ig doses received and overall [ Time Frame: Estimated for 1 year ]
  5. Payor type by investigator site [ Time Frame: Estimated for baseline and 1 year ]
  6. Insurance reimbursement issues [ Time Frame: Estimated for baseline and 1 year ]
  7. Concomitant medication use by disease type and therapeutic indication [ Time Frame: Estimated for baseline and 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01109810

Contact: L. Allyson Checkley, PhD 303.672.8888
Contact: Loretta Kristofek, RN 321-206-3969

United States, Colorado
Coram Clinical Trials Recruiting
Denver, Colorado, United States, 80202
Contact: L. Allyson Checkley, PhD    303-672-8888   
Contact: Loretta Kristofek, RN    321.206.3969   
Principal Investigator: Luqman Seidu, MD         
Sponsors and Collaborators
Coram Clinical Trials
Principal Investigator: Luqman Seidu, MD Unaffilated

Publications of Results:
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

Responsible Party: Coram Clinical Trials Identifier: NCT01109810     History of Changes
Other Study ID Numbers: CT-10-02
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs