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

NCT01109810 | Completed

• 1 other identifier: CT-10-02
• Study Type: observational
• Target: 496
• Locations: 1 country
• Sites: 1

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

Conditions

IVIg or SCIg Therapy in the Home or at Alternate Site

Outcome Measures

Primary Outcomes (2)

• Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic)

  Recorded from referral form

  Baseline

• Infection incidence by route, dose, and age

  Infection incidence, route, dose recorded from Clinical Progress reports Immune Replacement Efficacy section

  every 6 months

Secondary Outcomes (7)

• Dosing information by disease type, Investigative Site, and therapeutic indication

  Estimated for baseline and 1 year

• Adverse events and serious adverse events by disease type and relation to Ig therapy

  Estimated for baseline and 1 year

• IVIg vs SCIg by disease type and geographic region (and/or investigative site)

  Baseline

• Current state of disease by number of Ig doses received and overall

  Estimated for 1 year

• Payor type by investigator site

  Estimated for baseline and 1 year

Study Arms (1)

IVIg and SCIg therapy

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coram Clinical Trials: lead

Study Sites (1)

Coram Clinical Trials

Centennial, Colorado, 80112, United States

Location

Related Publications (3)

• 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

  BACKGROUND

• 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.

  PMID: 28345437 RESULT

• 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

  RESULT

Study Officials

• Luqman Seidu, MD

  Omni Allergy, Immunology, and Asthma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 23, 2010
• Study Start: September 8, 2010
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

US (1)