A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care
NCT Number: NCT06538064
Acronym: HYbISCUE
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Interventions: OTHER: No Intervention
Sponsor: Takeda
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-13
Completion Date: 2027-08-17

Summary:
The main aims of this study are to understand why adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) chose a certain treatment, why they changed to HyQvia from another therapy, how satisfied they are with HyQvia and their previous treatment, how their work productivity and activity is impacted and learn about their CIDP signs and symptoms. Other aims are to collect information on any medical problems or side effects during the treatment with HyQvia, learn how effective treatment of CIDP with HyQvia is and understand details on the use of HyQvia in standard clinical routine as well on the need for healthcare intervention (such as emergency room visits or hospital visits or stays).

During the study, data will be collected from medical records already available, interviews with participants at study start and study completion and via questionnaires completed by participants.

Participants will be treated as per the doctor's or the clinic's routine.

Primary Outcome Measures: Treatment Preference for CIDP Therapy as Measured by Novel Treatment Preference Questionnaires, The novel treatment preference questionnaires measure participant's treatment preferences for switching to HyQvia from other subcutaneous immunoglobulin/intravenous immunoglobulin (SCIG/IVIG) treatments for CIDP. It includes overall preference for switching from prior therapy to HyQvia, reason for switching from prior therapy type (like other SCIG, IVIG, corticosteroids, or plasma exchange) to HyQvia for the maintenance treatment of CIDP, current/future preference for HyQvia, reason for HyQvia or study discontinuation, and details on previous treatment setting/components for other subcutaneous immunoglobulin (SCIG) or intravenous immunoglobulin (IVIG) user only. Users will be presented a maximum of 8 questions at baseline, 2 questions at Month 12, 2 questions if HyQvia is discontinued, and 4 questions if the study is discontinued. The questionnaires will be self-administered., Baseline up to 12 months (HyQvia or study discontinuation)|Treatment Satisfaction With HyQvia as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) Short Form-9, The TSQM is a 9-item questionnaire which assesses domains that include effectiveness, convenience, and global satisfaction. The instrument is self-administered. Response options fall on a 5- or 7-point Likert/Likert-type scale with scores ranging from 0 to 100 and higher scores indicating a higher level of treatment satisfaction., Baseline up to 12 months|Health-Related Quality of Life (HRQoL) as Measured by the Chronic Acquired Polyneuropathy Patient Reported Index (CAP-PRI), The CAP-PRI is a disease-specific HRQoL measure designed to assess diabetic polyneuropathy. This 15-item questionnaire assesses various life domains including physical and social functioning, pain, and emotional well-being. Items will be scored 0 (not at all), 1 (a little bit), or 2 (a lot). Individual scores within the CAP-PRI may be summed to a total score ranging from 0 to 30 that indicates the level of disease impairment, with higher scores representing higher degrees of impairment., Baseline up to 12 months|CIDP Signs, Symptoms, and Impacts, as Measured by the Inflammatory Rasch-built Overall Disability Scale (I-RODS), The I-RODS is a linearly weighted scale developed to capture activity and social participation limitations in participants with Guillain-Barré syndrome and CIDP. This 24-item questionnaire assesses domains that include activity and social participation. Response options include a categorical rating scale where 0 is "Not possible to perform," 1 is "Possible with some difficulty," and 2 is "Possible, without any difficulty," with a lower score indicating more severe activity and social participation limitations., Baseline up to 12 months (HyQvia or study discontinuation)|Productivity as Measured by the Work Productivity and Activity Impairment (WPAI), The WPAI is a 6-item questionnaire that assesses domains that include absenteeism (missing work), presenteeism (impaired productivity at work), overall work performance (combined absenteeism and presenteeism), and non-work activities (activity impairment. Outcomes as measured by the WPAI are expressed as impairment percentages i.e., 0% (best) to 100% (worst), with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes., Baseline up to 12 months
Secondary Outcome Measures: Number of Participants With Serious Adverse Events (SAEs) and All Non-serious Adverse Events (AEs) Causally or Temporally Relationship to HyQvia Treatment, SAE is any untoward medical occurrence that at any dose: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event in opinion of healthcare provider, may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above. Non-serious AEs are the AEs that do not meet SAEs definition. Related AE: AE that follows a reasonable temporal sequence from administration of medication, vaccine, or device (including the course after withdrawal of the medication), and for which a causal relationship is at least a reasonable possibility, i.e., relationship cannot be ruled out, although factors other than medication, vaccine or device, such as underlying diseases, complications, concomitant drugs and concurrent treatments, may also have contributed., Baseline up to 12 months|Number of Participants With Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Increase of >=1 point Relative to the Baseline, The INCAT disability score is a measure of activity limitation. The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates 'no upper limb problems' and arm = 5 indicates 'inability to use either arm for any purposeful movement', and leg = 0 indicates 'walking not affected', and leg = 5 indicates 'restricted to wheelchair, unable to stand and walk a few steps with help'). Thus, a higher INCAT disability score indicates greater disability. The adjusted INCAT disability score remains identical to INCAT disability score, except that the changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded., Baseline up to 12 months|Change From Baseline in Adjusted INCAT Disability Score, The INCAT disability score is a measure of activity limitation. The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates 'no upper limb problems' and arm = 5 indicates 'inability to use either arm for any purposeful movement', and leg = 0 indicates 'walking not affected', and leg = 5 indicates 'restricted to wheelchair, unable to stand and walk a few steps with help'). Thus, a higher INCAT disability score indicates greater disability. The adjusted INCAT disability score remains identical to INCAT disability score, except that the changes in upper limb function from 0 (normal) to 1 (minor symptoms) are excluded., Baseline up to 12 months|Change From Baseline in Hand Grip Strength, Grip strength assessments conducted by prescribing physicians using the Martin Vigorimeter or the Jamar Dynamometer (as available at the site and performed per routine clinical practice)., Baseline up to 12 months|Change from Baseline in Medical Research Council (MRC) Score, The MRC sum score measures muscle strength from both the left and right sides of the body on a scale of 0 to 5. The total MRC sum score ranges from 0 (paralysis) to 60 (normal strength), where higher score indicates better strength., Baseline up to 12 months|Change From Baseline in I-RODS Centile Score, The I-RODS is a linearly weighted scale developed to capture activity and social participation limitations in participants with Guillain-Barré syndrome and CIDP. This 24-item questionnaire assesses domains that include activity and social participation. The instrument is self-administered, takes 5-10 minutes to complete, and the data will be collected electronically. Response options include a categorical rating scale where 0 is "Not possible to perform," 1 is "Possible with some difficulty," and 2 is "Possible, without any difficulty," with a lower score indicating more severe activity and social participation limitations., Baseline up to 12 months|Treatment Utilization of HyQvia, Data will be reported as average total dose per infusion (mg); proportions of participants with dose as prescribed/planned by physician and with at least one ramp-up infusion; average number of ramp-up doses per participant; average infusion duration (minutes); proportions of participants with treatment intervals at every 2, 3, 4, 5, and 6 weeks; average maximum infusion rate (milliliter/hour\[mL/h\]); average number of infusion sites per infusion; proportion of participants using 6mm, 8mm, 9mm, 12mm, 14mm, 16mm, and other needle lengths; proportions of participants using 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, and other needle gauges; proportions of participants using various infusion pump types; proportions of participants receiving infusions at home, hospital, doctor's office, and other; proportions of participants administering infusions by self, caregiver, or HCP; average adherence; proportion of participants who discontinue HyQvia treatment and their reason of discontinuation., Baseline, Month 3, Month 6, Month 9, and Month 12 (as available)|Healthcare Resource Utilization (HCRU), Data will be reported as number of participants with at least one and average number of emergency room visits; number of participants with at least one and average number of outpatient office visits; number of participants with at least one and average number of hospitalizations; average number of emergency room visits due to severity of AEs within 7 business days of an infusion; average number of outpatient office visits due to severity of AEs within 7 business days of an infusion; average number of hospitalizations due to severity of AEs within 7 business days of an infusion; proportions of participants receiving caregiver or HCP support for infusions., Baseline, Month 3, Month 6, Month 9, and Month 12 (as available)