Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)

Baxalta now part of Shire126 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

126

Conditions

Primary Immunodeficiency Diseases (PID)

Interventions

CUVITRUBIOLOGICAL

CUVITRU

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

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

Locations (3)

University of McMaster

Hamilton, Ontario, Canada

Grand River Allergy

Kitchener, Ontario, Canada

Toronto Allergists

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Infusion parameter 1: Cohort 1-Start of data collection

Median infusion volume per site

Time frame: Baseline

Infusion parameter 1: Cohort 1- Month 3

Median infusion volume per site

Time frame: Month 3

Infusion parameter 1: Cohort 1- Month 6

Median infusion volume per site

Time frame: Month 6

Infusion parameter 1: Cohort 1- 12 Month final follow-up

Median infusion volume per site

Time frame: 12 Month final follow-up

Infusion parameter 1: Cohort 2- Start of data collection

Median infusion volume per site

Time frame: Baseline

Infusion parameter 1: Cohort 2- 12 Month final follow-up

Median infusion volume per site

Time frame: 12 Month final follow-up

Infusion parameter 1.1: Cohort 1- Start of data collection

Median infusion volume per infusion

Time frame: Baseline

Infusion parameter 1.1: Cohort 1- Month 3

Median infusion volume per infusion

Time frame: Month 3

Infusion parameter 1.1: Cohort 1- Month 6

Median infusion volume per infusion

Time frame: Month 6

Data from ClinicalTrials.gov

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Infusion parameter 1.1: Cohort 1- 12 Month final follow-up

Median infusion volume per infusion

Time frame: 12 Month final follow-up

Infusion parameter 1.1: Cohort 2- Start of data collection

Median infusion volume per infusion

Time frame: Baseline

Infusion parameter 1.1: Cohort 2- 12 Month final follow-up

Median infusion volume per infusion

Time frame: 12 Month final follow-up

Infusion parameter 2: Cohort 1- Start of data collection

Median number of infusion sites

Time frame: Baseline

Infusion parameter 2: Cohort 1- Month 3

Median number of infusion sites

Time frame: Month 3

Infusion parameter 2: Cohort 1- Month 6

Median number of infusion sites

Time frame: Month 6

Infusion parameter 2: Cohort 1- 12 Month final follow-up

Median number of infusion sites

Time frame: 12 Month final follow-up

Infusion parameter 2: Cohort 2- Start of data collection

Median number of infusion sites

Time frame: Baseline

Infusion parameter 2: Cohort 2- 12 Month final follow-up

Median number of infusion sites

Time frame: 12 Month final follow-up

Infusion parameter 3: Cohort 1- Start of data collection

Median infusion duration

Time frame: Baseline

Infusion parameter 3: Cohort 1- Month 3

Median infusion duration

Time frame: Month 3

Infusion parameter 3: Cohort 1- Month 6

Median infusion duration

Time frame: Month 6

Infusion parameter 3: Cohort 1- 12 Month final follow-up

Median infusion duration

Time frame: 12 Month final follow-up

Infusion parameter 3: Cohort 2- Start of data collection

Median infusion duration

Time frame: Baseline

Infusion parameter 3: Cohort 2- 12 Month final follow-up

Median infusion duration

Time frame: 12 Month final follow-up

Infusion parameter 3.1: Cohort 1- Month 3 Follow-up

Median number of infusions to reach participant's maximum infusion volume

Time frame: Month 3

Infusion parameter 3.1: Cohort 1- Month 6 Follow-up

Median number of infusions to reach participant's maximum infusion volume

Time frame: Month 6

Infusion parameter 3.1: Cohort 1- 12 Month final follow-up

Median number of infusions to reach participant's maximum infusion volume

Time frame: 12 Month final follow-up

Infusion parameter 3.1: Cohort 2- 12 Month final follow-up

Median number of infusions to reach participant's maximum infusion volume

Time frame: 12 Month final follow-up

Infusion parameter 3.2: Cohort 1- Start of data collection

Median number of infusions per month per participant

Time frame: Baseline

Infusion parameter 3.2: Cohort 1- Month 3

Median number of infusions per month per participant

Time frame: Month 3

Infusion parameter 3.2: Cohort 1- Month 6

Median number of infusions per month per participant

Time frame: Month 6

Infusion parameter 3.2: Cohort 1- 12 Month final follow-up

Median number of infusions per month per participant

Time frame: 12 Month final follow-up

Infusion parameter 3.2: Cohort 2- Start of data collection

Median number of infusions per month per participant

Time frame: Baseline

Infusion parameter 3.2: Cohort 2- 12 Month final follow-up

Median number of infusions per month per participant

Time frame: 12 Month final follow-up

Infusion parameter 3.3: Cohort 1- Start of data collection

Median number of infusions to reach final dose interval per participant

Time frame: Baseline

Infusion parameter 3.3: Cohort 1- Month 3

Median number of infusions to reach final dose interval per participant

Time frame: Month 3

Infusion parameter 3.3: Cohort 1- Month 6

Median number of infusions to reach final dose interval per participant

Time frame: Month 6

Infusion parameter 3.3: Cohort 1- 12 Month final follow-up

Median number of infusions to reach final dose interval per participant

Time frame: 12 Month final follow-up

Infusion parameter 3.3: Cohort 2- Start of data collection

Median number of infusions to reach final dose interval per participant

Time frame: Baseline

Infusion parameter 3.3: Cohort 2- 12 Month final follow-up

Median number of infusions to reach final dose interval per participant

Time frame: 12 Month final follow-up

Infusion parameter 1: Cohort 3- 12 Month Final Follow-up

Median infusion volume per site.

Time frame: 12 Month final follow-up

Infusion parameter 1.1: Cohort 3- 12 Month Final Follow-up

Median infusion volume per infusion.

Time frame: 12 Month final follow-up

Infusion parameter 2: Cohort 3- 12 Month final follow-up

Median number of infusion sites.

Time frame: 12 Month final follow-up

Infusion parameter 3: Cohort 3- 12 Month final follow-up

Median infusion duration.

Time frame: 12 Month final follow-up

Infusion parameter 3.1: Cohort 3- 12 Month final follow-up

Median number of infusions to reach participant's maximum infusion volume (infusion rate)

Time frame: 12 Month final follow-up

Infusion parameter 3.2: Cohort 3- 12 Month final follow-up

Median number of infusions per month per participant

Time frame: 12 Month final follow-up

Infusion parameter 3.3: Cohort 3- 12 Month final follow-up

Median number of infusions to reach final dose interval per participant

Time frame: 12 Month final follow-up

Secondary Outcomes

Infusion parameter 4.1: Cohort 1- Start of data collection

Median maximal infusion rate per site

Time frame: Baseline

Infusion parameter 4.1: Cohort 1- Month 3

Median maximal infusion rate per site

Time frame: Month 3

Infusion parameter 4.1: Cohort 1- Month 6

Median maximal infusion rate per site

Time frame: Month 6

Infusion parameter 4.1: Cohort 1- 12 Month final follow-up

Median maximal infusion rate per site

Time frame: 12 Month final follow-up

Infusion parameter 4.1: Cohort 2- Start of data collection

Median maximal infusion rate per site

Time frame: Baseline

Infusion parameter 4.1: Cohort 2- 12 Month final follow-up

Median maximal infusion rate per site

Time frame: 12 Month final follow-up

Infusion parameter 4.2: Cohort 1- Start of data collection

Number of infusions that are discontinued, slowed, or interrupted

Time frame: Baseline

Infusion parameter 4.2: Cohort 1- Month 3

Number of infusions that are discontinued, slowed, or interrupted

Time frame: Month 3

Infusion parameter 4.2: Cohort 1- Month 6

Number of infusions that are discontinued, slowed, or interrupted

Time frame: Month 6

Infusion parameter 4.2: Cohort 1- 12 Month final follow-up

Number of infusions that are discontinued, slowed, or interrupted

Time frame: 12 Month final follow-up

Infusion parameter 4.2: Cohort 2- Start of data collection

Number of infusions that are discontinued, slowed, or interrupted

Time frame: Baseline

Infusion parameter 4.2: Cohort 2- 12 Month final follow-up

Number of infusions that are discontinued, slowed, or interrupted

Time frame: 12 Month final follow-up

Infusion parameter 4.3: Cohort 1- Month 3

Median number of infusions to reach participant's maximum infusion rate

Time frame: Month 3

Infusion parameter 4.3: Cohort 1- Month 6

Median number of infusions to reach participant's maximum infusion rate

Time frame: Month 6

Infusion parameter 4.3: Cohort 1- 12 Month final follow-up

Median number of infusions to reach participant's maximum infusion rate

Time frame: 12 Month final follow-up

Infusion parameter 4.3: Cohort 2- 12 Month final follow-up

Median number of infusions to reach participant's maximum infusion rate

Time frame: 12 Month final follow-up

Infusion parameter 5.1: Cohort 1- Start of data collection

Mean dose

Time frame: Baseline

Infusion parameter 5.1: Cohort 1- Month 3

Mean dose

Time frame: Month 3

Infusion parameter 5.1: Cohort 1- Month 6

Mean dose

Time frame: Month 6

Infusion parameter 5.1: Cohort 1- 12 Month final follow-up

Mean dose

Time frame: 12 Month final follow-up

Infusion parameter 5.1: Cohort 2- Start of data collection

Mean dose

Time frame: Baseline

Infusion parameter 5.1: Cohort 2- 12 Month final follow-up

Mean dose

Time frame: 12 Month final follow-up

Infusion parameter 5.2: Cohort 1- Start of data collection

Mean dosing interval

Time frame: Baseline

Infusion parameter 5.2: Cohort 1- Month 3

Mean dosing interval

Time frame: Month 3

Infusion parameter 5.2: Cohort 1- Month 6

Mean dosing interval

Time frame: Month 6

Infusion parameter 5.2: Cohort 1- 12 Month final follow-up

Mean dosing interval

Time frame: 12 Month final follow-up

Infusion parameter 5.2: Cohort 2- Start of data collection

Mean dosing interval

Time frame: Baseline

Infusion parameter 5.2: Cohort 2- 12 Month final follow-up

Mean dosing interval

Time frame: 12 Month final follow-up

Infusion parameter 5.3: Cohort 1- Start of data collection

Mean number of dose adjustments

Time frame: Baseline

Infusion parameter 5.3: Cohort 1- Month 3

Mean number of dose adjustments

Time frame: Month 3

Infusion parameter 5.3: Cohort 1- Month 6

Mean number of dose adjustments

Time frame: Month 6

Infusion parameter 5.3: Cohort 1- 12 Month final follow-up

Mean number of dose adjustments

Time frame: 12 Month final follow-up

Infusion parameter 5.3: Cohort 2- Start of data collection

Mean number of dose adjustments

Time frame: Baseline

Infusion parameter 5.3: Cohort 2- 12 Month final follow-up

Mean number of dose adjustments

Time frame: 12 Month final follow-up

Infusion parameter 4.1: Cohort 3- 12 Month final follow-up

Median maximal infusion rate per site

Time frame: 12 Month final follow-up

Infusion parameter 4.2: Cohort 3- 12 Month final follow-up

Number of infusions that are discontinued, slowed, or interrupted

Time frame: 12 Month final follow-up

Infusion parameter 4.3: Cohort 3- 12 Month final follow-up

Median number of infusions to reach participant's maximum infusion rate

Time frame: 12 Month final follow-up

Infusion parameter 5.1: Cohort 3- 12 Month final follow-up

Mean dose

Time frame: 12 Month final follow-up

Infusion parameter 5.2: Cohort 3- 12 Month final follow-up

Mean dosing interval

Time frame: 12 Month final follow-up

Infusion parameter 5.3: Cohort 3- 12 Month final follow-up

Mean number of dose adjustments

Time frame: 12 Month final follow-up

Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 1

TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant's satisfaction with medication. The three domains assessed are effectiveness (3 items), convenience (3 items), and global satisfaction (3 items). Scores for each domain are calculated by adding up the items in each domain and then transforming the composite score into a value ranging from 0 to 100. Higher score indicated greater satisfaction in that domain.

Time frame: 12 Month final follow-up

Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 2

Time frame: 12 Month final follow-up

Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 3

Time frame: 12 Month final follow-up

Life Quality Index (LQI): Cohort 1

The LQI is a self-administered questionnaire developed specifically for participants/legal guardians involved in IVIG treatments. It consists of 15-items, divided into four domains: treatment interferences (6 items), therapy-related problems (4 items), therapy setting (3 items), and treatment costs (2 items). Items are rated on a 7-point Likert-type scale ranging from 1: "Extremely bad" to 7: "Extremely good". Total scores range from 15 to 105, with higher scores indicating the highest possible satisfaction with factors such as independence, therapy convenience, social/school/work activities, and health and travel costs.

Time frame: 12 Month final follow-up

Life Quality Index (LQI): Cohort 2

Time frame: 12 Month final follow-up

Life Quality Index (LQI): Cohort 3

Time frame: 12 Month final follow-up

Treatment Preference Questionnaire (TPQ): Cohort 1

The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's reference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.

Time frame: 12 Month final follow-up

Treatment Preference Questionnaire (TPQ): Cohort 2

The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.

Time frame: 12 Month final follow-up

Treatment Preference Questionnaire (TPQ): Cohort 3

The TPQ is a self-administered questionnaire developed to assess participants' preference towards the administration of new subcutaneous immunoglobulin G (SCIG) therapy. There are 4-items on the questionnaire, which investigate a participant's preference on the clinic/hospital/home setting of receiving the immunoglobulin therapy, the participant's rating on the frequency and method of administration, and the participant's preference to continue receiving the SCIG treatment.

Time frame: 12 Month final follow-up