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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Coram Clinical Trials
Sponsor:
Information provided by (Responsible Party):
Coram Clinical Trials
ClinicalTrials.gov Identifier:
NCT01109810
First received: April 21, 2010
Last updated: February 4, 2014
Last verified: February 2014
  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™)

Further study details as provided by Coram Clinical Trials:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 Study Completion Date: August 2025
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109810

Contacts
Contact: Sean Kearns, Ph.D 303.672.8610 sean.kearns@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: 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         
Sponsors and Collaborators
Coram Clinical Trials
Investigators
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: February 4, 2014
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 August 20, 2014