An observational study in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), sponsored by Takeda. Recruiting at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Takeda · Observational
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.
129 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 49 are open to participants now.
This study's planned enrollment of 30 is below the median of 48 across 39 observational studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population is participants with a confirmed clinical diagnosis of CIDP, who are in the process of switching from any prior CIDP therapy to HyQvia for maintenance treatment of CIDP. The participants population will be comprised of both new users (Cohort A) and current users (Cohort B) of HyQvia.
Is considered a new user or current user of HyQvia-
Exclusion Criteria:
Had any HyQvia use, defined as
Participants with CIDP who intend to switch to HyQvia within 6 weeks after enrollment will be interviewed and data from medical records will be reviewed for 12 months.
Other: No Intervention
Participants with CIDP who switched to HyQvia within 6 weeks prior to enrollment will be interviewed and data from medical records will be reviewed for 12 months.
Other: No Intervention
This is a non-interventional study.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 3, Month 6, Month 9, and Month 12 (as available)
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating→
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