Clinical trial NCT03716700: Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)
Official title: Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immunodeficiency Diseases (PID)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Baxalta Innovations GmbH, now part of Shire
First posted: 2018-10-23
Enrollment: 126
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected on approximately 500 participants with primary immunodeficiency (PID) and secondary immunodeficiency (SID) requiring Immunoglobulin G (IgG) replacement therapy across 8-10 sites in Canada (excluding Quebec). Any specific number of participants in each cohort is not a requirement.

Brief summary: This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.


Eligibility criteria: Inclusion Criteria (The participant will not be considered eligible for the study without meeting all of the criteria below):

* Voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent or assent as applicable to participate in the study;
* Participant \> 2 years of age with a documented diagnosis of PID or SID requiring IgG replacement therapy, as defined by the International Union of Immunological Societies Scientific Committee 2009 and by diagnostic criteria according to Conley et al., 1999;
* Participant has received subcutaneous immunoglobulin (SCIG) therapy previous to CUVITRU for at least 3 months; and
* Participant has received CUVITRU in line with the product specification (CUVITRU Product Monograph (Baxalta Canada Corporation, 2018) at start of study

Exclusion Criteria (Participants are excluded from the study if any of the following criteria are met):

* Participation in any interventional clinical study within the last 30 days
* Participant participates in a clinical study in parallel during the observation period; and
* Participant had a dose change 30 days prior to transition to CUVITRU for Cohort 1

Primary outcomes:
measure: Infusion parameter 1: Cohort 1-Start of data collection
timeFrame: Baseline
measure: Infusion parameter 1: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 1: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 1: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 1: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 1: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 1.1: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 1.1: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 1.1: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 1.1: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 1.1: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 1.1: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 2: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 2: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 2: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 2: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 2: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 2: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 3: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 3: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 3: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 3: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3.1: Cohort 1- Month 3 Follow-up
timeFrame: Month 3
measure: Infusion parameter 3.1: Cohort 1- Month 6 Follow-up
timeFrame: Month 6
measure: Infusion parameter 3.1: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3.1: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3.2: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 3.2: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 3.2: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 3.2: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3.2: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 3.2: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3.3: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 3.3: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 3.3: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 3.3: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3.3: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 3.3: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 1: Cohort 3- 12 Month Final Follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 1.1: Cohort 3- 12 Month Final Follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 2: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3.1: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3.2: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 3.3: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
Secondary outcomes:
measure: Infusion parameter 4.1: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 4.1: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 4.1: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 4.1: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 4.1: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 4.1: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 4.2: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 4.2: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 4.2: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 4.2: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 4.2: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 4.2: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 4.3: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 4.3: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 4.3: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 4.3: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 5.1: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 5.1: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 5.1: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 5.1: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 5.1: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 5.1: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 5.2: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 5.2: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 5.2: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 5.2: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 5.2: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 5.2: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 5.3: Cohort 1- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 5.3: Cohort 1- Month 3
timeFrame: Month 3
measure: Infusion parameter 5.3: Cohort 1- Month 6
timeFrame: Month 6
measure: Infusion parameter 5.3: Cohort 1- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 5.3: Cohort 2- Start of data collection
timeFrame: Baseline
measure: Infusion parameter 5.3: Cohort 2- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 4.1: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 4.2: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 4.3: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 5.1: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 5.2: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Infusion parameter 5.3: Cohort 3- 12 Month final follow-up
timeFrame: 12 Month final follow-up
measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 1
timeFrame: 12 Month final follow-up
measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 2
timeFrame: 12 Month final follow-up
measure: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 3
timeFrame: 12 Month final follow-up
measure: Life Quality Index (LQI): Cohort 1
timeFrame: 12 Month final follow-up
measure: Life Quality Index (LQI): Cohort 2
timeFrame: 12 Month final follow-up
measure: Life Quality Index (LQI): Cohort 3
timeFrame: 12 Month final follow-up
measure: Treatment Preference Questionnaire (TPQ): Cohort 1
timeFrame: 12 Month final follow-up
measure: Treatment Preference Questionnaire (TPQ): Cohort 2
timeFrame: 12 Month final follow-up
measure: Treatment Preference Questionnaire (TPQ): Cohort 3
timeFrame: 12 Month final follow-up
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: University of McMaster
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Allergy
state: Ontario
city: Toronto
country: Canada
facility: Toronto Allergists
state: Ontario
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Keith PK, Cowan J, Kanani A, Kim H, Lacuesta G, Lee JK, Chen J, Park M, Gladiator A. Transitioning subcutaneous immunoglobulin 20% therapies in patients with primary and secondary immunodeficiencies: Canadian real-world study. Allergy Asthma Clin Immunol. 2022 Aug 7;18(1):70. doi: 10.1186/s13223-022-00709-8.