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

2014-08-27 03:14:12 | BioPortfolio

Summary

The objective of the IDEaL Registry is to allow physicians, scientists, and patients the opportunity to obtain an overall profile of real-world "effectiveness" data associated with Ig therapy.

Description

This is a prospective, longitudinal, observational registry study to provide a unique and effective mechanism to acquire real-world data on product prescribing, product use by patients, and product performance for patients receiving Ig therapy (IVIg and SCIg) in a homecare and/or ambulatory infusion setting, regardless of disease treated. There is no limit on the number of people that may participate in the registry. The IDEaL Registry will be overseen by a single Principal Investigator. Coram estimates that approximately 40 sites in the US will participate as submitting centers in this registry, but there will be no limit to this number. Any and all patients being treated with Ig therapy who have not yet begun to use Coram's home and/or ambulatory infusion services will be invited to participate in this study.

Participation in the registry will continue as long as the subject is:

- Being treated with Ig replacement therapy (this does not include monoclonal antibody therapy),

- Using Coram's home and/or ambulatory infusion services,

- Willing to participate in this registry, and

- Until the Sponsor or Principal Investigator decide to terminate their participation in the IDEaL Registry.

The data entry for this study differs from other registries in that the data that is going into the registry is being collected by the homecare agency (pharmacy and nurses). The data collected for the IDEaL Registry will be collected on the standard Physician Order, Nursing Records, etc. Copies of these are sent to the study doctors for their standard patient medical records, as is standard for the homecare approach. For the IDEaL Registry, data routinely entered into Coram's database will be processed in the same manner as for non-registry patients, but will be extracted in a systematic fashion for incorporation into the IDEaL Registry. The other standard forms, and the Registry-specific Quality of Life Questionnaire form will also be sent to Coram to be entered into the IDEaL Registry.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

IVIg and SCIg Therapy in the Home or at an Alternate Site

Location

OmniaVincit, LLC
Denver
Colorado
United States
80238

Status

Recruiting

Source

Coram Clinical Trials

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:12-0400

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Medical and Biotech [MESH] Definitions

Use of any infusion therapy on an ambulatory, outpatient, or other non-institutionalized basis.

Nursing care given to an individual in the home. The care may be provided by a family member or a friend. Home nursing as care by a non-professional is differentiated from HOME CARE SERVICES provided by professionals: visiting nurse, home health agencies, hospital, or other organized community group.

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