IVIg or SCIg Therapy in the Home or at Alternate SiteIDEaLNCT01109810
Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™)
An observational study of IVIg or SCIg Therapy in the Home or at Alternate Site, run by Coram Clinical Trials at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- IVIg or SCIg Therapy in the Home or at Alternate Site
- Type of treatment
- Injection or infusion
- How many people
- 496 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2010to 10 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVIg and SCIg therapy | Patients receiving Ig therapy by IV or SC route in the home or alternate site setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic)
Recorded from referral form
Measured: Baseline
Infection incidence by route, dose, and age
Infection incidence, route, dose recorded from Clinical Progress reports Immune Replacement Efficacy section
Measured: every 6 months
Secondary outcomes (7)
Dosing information by disease type, Investigative Site, and therapeutic indication
Dosing collected from Clinical Progress Reports and/or Medication Record
Measured: Estimated for baseline and 1 year
Adverse events and serious adverse events by disease type and relation to Ig therapy
Collected from Clinical Progress Reports Therapy Tolerance section
Measured: Estimated for baseline and 1 year
IVIg vs SCIg by disease type and geographic region (and/or investigative site)
Route collected from Clinical Progress Reports and/or Medication Record
Measured: Baseline
Current state of disease by number of Ig doses received and overall
Ig doses monitored by missed dose section of Clinical Progress Report and Shipping Records
Measured: Estimated for 1 year
Payor type by investigator site
Recorded from referral information
Measured: Estimated for baseline and 1 year
Insurance reimbursement issues
Obtained when patient has to discharge from study due to insurance change and Coram not a provider
Measured: Estimated for baseline and 1 year
Concomitant medication use by disease type and therapeutic indication
Collected from Medication Record
Measured: Estimated for baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study start8 Sep 2010
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IVIg or SCIg Therapy in the Home or at Alternate SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coram Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luqman Seidu, MD, Principal investigator, Omni Allergy, Immunology, and Asthma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109810
- Sponsor's protocol ID
- CT-10-02
- Acronym
- IDEaL
- Status last verified
- Jun 2022
- First submitted
- 21 Apr 2010
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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
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.
PubMed 28345437P259 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoglobulin, Diagnosis, Evaluation, and Key Learnings Patient Registry (IDEaL™)
- ClinicalTrials.gov ID
- NCT01109810
- Acronym / sponsor ID
- IDEaL / CT-10-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Coram Clinical TrialsUniversity, hospital or other
- Study start
- 8 Sep 2010 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVIg and SCIg therapy | – | –Patients receiving Ig therapy by IV or SC route in the home or alternate site setting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic)
Time frame: Baseline
Recorded from referral form
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
7 secondary outcomes
Dosing information by disease type, Investigative Site, and therapeutic indication
Time frame: Estimated for baseline and 1 year
Adverse events and serious adverse events by disease type and relation to Ig therapy
Time frame: Estimated for baseline and 1 year
IVIg vs SCIg by disease type and geographic region (and/or investigative site)
Time frame: Baseline
Current state of disease by number of Ig doses received and overall
Time frame: Estimated for 1 year
Payor type by investigator site
Time frame: Estimated for baseline and 1 year
Insurance reimbursement issues
Time frame: Estimated for baseline and 1 year
Concomitant medication use by disease type and therapeutic indication
Time frame: Estimated for baseline and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- BackgroundIMMUNOGLOBULIN 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
- Results publication: PubMed 28345437Kearns 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.
- Results publicationP259 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
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luqman Seidu, MD principal investigator
Omni Allergy, Immunology, and Asthma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVIg or SCIg Therapy in the Home or at Alternate Site, run by Coram Clinical Trials at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease by geographic region (and/or Investigative Site), age, therapeutic indication (immunologic/neurologic) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109810, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.