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Completed

NCT Number: NCT01109810

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Coram Clinical Trials

Centennial, Colorado, 80112, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

    Recorded from referral form

  2. Infection incidence by route, dose, and age

    Time frame: every 6 months

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

Secondary outcomes

  1. Dosing information by disease type, Investigative Site, and therapeutic indication

    Time frame: Estimated for baseline and 1 year

    Dosing collected from Clinical Progress Reports and/or Medication Record

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

    Time frame: Estimated for baseline and 1 year

    Collected from Clinical Progress Reports Therapy Tolerance section

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

    Time frame: Baseline

    Route collected from Clinical Progress Reports and/or Medication Record

  4. Current state of disease by number of Ig doses received and overall

    Time frame: Estimated for 1 year

    Ig doses monitored by missed dose section of Clinical Progress Report and Shipping Records

  5. Payor type by investigator site

    Time frame: Estimated for baseline and 1 year

    Recorded from referral information

  6. Insurance reimbursement issues

    Time frame: Estimated for baseline and 1 year

    Obtained when patient has to discharge from study due to insurance change and Coram not a provider

  7. Concomitant medication use by disease type and therapeutic indication

    Time frame: Estimated for baseline and 1 year

    Collected from Medication Record

Sponsors and collaborators

Lead sponsor

Coram Clinical Trials

Other

Registry information

Acronym: IDEaL

Important dates

Study start
2010
Primary completion
2022
Study completion
2022
First posted
Apr 23, 2010
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.