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

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ClinicalTrials.gov Identifier: NCT01109810
Recruitment Status : Recruiting
First Posted : April 23, 2010
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

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


Study Design

Study Type : Observational
Estimated Enrollment : 400 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
Groups and Cohorts

Group/Cohort
IVIg and SCIg therapy


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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.
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01109810


Contacts
Contact: L. Allyson Checkley, PhD 303.672.8888 laura.checkley@coramhc.com
Contact: Loretta Kristofek, RN 321-206-3969 loretta.kristofek@coramhc.com

Locations
United States, Colorado
Coram Clinical Trials Recruiting
Denver, Colorado, United States, 80202
Contact: L. Allyson Checkley, PhD    303-672-8888    laura.checkley@coramhc.com   
Contact: Loretta Kristofek, RN    321.206.3969    loretta.kristofek@coramhc.com   
Principal Investigator: Luqman Seidu, MD         
Sponsors and Collaborators
Coram Clinical Trials
Investigators
Principal Investigator: Luqman Seidu, MD Unaffilated
More Information

Publications:
Responsible Party: Coram Clinical Trials
ClinicalTrials.gov Identifier: NCT01109810     History of Changes
Other Study ID Numbers: CT-10-02
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs