D80.3
Conditions
Interventions
Group 1: Arm 1: Patients with primary immunodeficiency (PID), treated with CUVITRU according to the product labelling by hospital-based or office-based physicians, are documented at 3 time-points (inc
Concomitant diseases
Immunoglobulin (IgG) treatment history prior to CUVITRU
Previous subcutaneous immunoglobulins: experience with most recent infusion
CUVITRU: experience with most recent infusion
Infections
immunoglobulin trough levels
Health care utilisation
(training sessions, hospitalisations, rehabilitation stays)
TSQM-9 questionnaire
LQI questionnaire
Adverse Events and Pregnancy Reports.
Details on the CUVITRU treatment regimen including dose (total dose in mg/kg body weight per week) and the infusion interval will be collected. Changes to the
Sponsors
GWT-TUD GmbH, Abteilung Medizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with a documented diagnosis of a form of primary humoral immunodeficiency (PID) involving a defect in antibody formation and requiring gammaglobulin replacement 2. Subject has received any SCIG (subcutaneous immunoglobulin) product previous to CUVITRU for at least 3 month at a stable dose 3. Subject has received CUVITRU in line with the product specification (labelling) at the time of first documentation and is expected to continue treatment with this therapy in future 4. Subject or legally authorized representative has provided written informed consent 5. Subject is likely and willing to be available for follow-up documentation including patient-reported assessments
Exclusion criteria
Exclusion criteria: 1. Subject has experienced a dose change during 3 month previous to the time of CUVITRU initiation 2. Subject participates in a clinical study in parallel during the observation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum rate of CUVITRU infusion at 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Usage a. Maximum volume of CUVITRU infusion b. number of infusions until achievement of maximum rate and volume c. number of infusion sites d. infusion duration e. dose and dosing schedule f. number of dose adjustments g. number/proportion of infusions that are discontinued, slowed, or interrupted h. reasons for discontinued, slowed, or interrupted infusions i. type of pump and tubing, needle length j. number of infusions per month k. infusion volume per site l. number of infusions to reach final dose interval Differences in treatment interval, monthly dose, infusion rate, time for the infusion and number of infusion sites in comparison to the previous SCIG therapy. Targeted Adverse Events of interest Number and rate per patient-year of a. all local AEs b. all causally related and/or temporally associated AEs c. all infections Patient experience including satisfaction Patient experience will be measured using the TSQM9 and LQI questionnaires Healthcare resource use: a. Days not able to go to school or work b. Number of hospitalizations, indication for the hospitalization (infection or non- infection) and days hospitalized c. Number of acute physician visits (office and emergency room) due to infection or other illnesses. | — |
Countries
Germany, Switzerland
Contacts
Public ContactRomy Wagner
GWT-TUD GmbH, Abteilung Medizin
Outcome results
None listed