A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care
HYbISCUE
A Global Real-World Study to Assess HyQvia Use and Outcomes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Switching to HyQvia
2 other identifiers
observational
30
3 countries
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2025
Typical duration for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2024
CompletedFirst Posted
Study publicly available on registry
August 5, 2024
CompletedStudy Start
First participant enrolled
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 17, 2027
November 21, 2025
November 1, 2025
2.3 years
July 31, 2024
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (8)
Number of Participants With Serious Adverse Events (SAEs) and All Non-serious Adverse Events (AEs) Causally or Temporally Relationship to HyQvia Treatment
Baseline up to 12 months
Number of Participants With Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Increase of >=1 point Relative to the Baseline
Baseline up to 12 months
Change From Baseline in Adjusted INCAT Disability Score
Baseline up to 12 months
Change From Baseline in Hand Grip Strength
Baseline up to 12 months
Change from Baseline in Medical Research Council (MRC) Score
Baseline up to 12 months
- +3 more secondary outcomes
Study Arms (2)
Cohort A: New Users of HyQvia
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.
Cohort B: Current Users of HyQvia
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.
Interventions
This is a non-interventional study.
Eligibility Criteria
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.
You may qualify if:
- Participants aged 18 years or older.
- Investigator-confirmed documented diagnosis of CIDP of any type (e.g., typical, multifocal, focal, motor, sensory, or distal) according to the revised European Academy of Neurology and Peripheral Nerve Society (EAN/PNS) 2021 guidelines on the diagnosis and treatment of CIDP.
- Participants must currently have a stable disease course (as per physician judgment) for at least 12 weeks.
- Is considered a new user or current user of HyQvia-
- New users (Cohort A) are participants on a CIDP treatment as of the date of enrollment, who intend to switch to HyQvia within 6 weeks after enrollment.
- Current users (Cohort B) are participants on HyQvia as of the date of enrollment, who switched to HyQvia within the 6 weeks preceding the date of enrollment (the 6-week window may be extended depending on the recruitment progress).
- Has provided written informed consent (for the main study).
- Participant is willing to comply with the protocol requirement of non-standard of care (non-SOC) assessments (e.g., adjusted inflammatory neuropathy cause and treatment (INCAT) assessment).
- Participants must be able to communicate fluently in their local language (if they participate in the optional qualitative participant interview \[sub-study\].
You may not qualify if:
- Had any HyQvia use, defined as
- any record of HyQvia use prior to enrollment for new users of HyQvia (Cohort A), and
- any record of HyQvia use more than 6 weeks preceding the enrollment date (the 6-week window may be extended depending on the recruitment progress) for current users of HyQvia (Cohort B).
- Without any prior treatment for CIDP.
- Pregnant or breastfeeding.
- Participants with known hypersensitivity to any component of HyQvia.
- Has participated in an interventional clinical study within 30 days prior to enrollment or was scheduled to participate in an interventional clinical study during this study.
- Has had major surgery within 12 weeks prior to enrollment, or has surgery planned during the time the participant is expected to participate in the study. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgeries.
- Received induction treatment for CIDP during the past 12 weeks.
- Participant is identified by the investigator as being unable or unwilling to cooperate with the study procedures.
- (Cohort A) only: Participants who do not initiate HyQvia treatment within 6 weeks after enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (15)
Samir Macwan MD Inc
Rancho Mirage, California, 92270, United States
Neuro/Psych Sleep Clinic
San Francisco, California, 94143, United States
Yale School Of Medicine
New Haven, Connecticut, 06510, United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33713, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
HSHS St. Elizabeths Hospital
O'Fallon, Illinois, 62269, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160, United States
Wake Forest University - School of Medicine - Central
Winston-Salem, North Carolina, 27157, United States
Arhus Universtitetshospital
Aarhus N, 8200, Denmark
Rigshospitalet
København Ø, 2100, Denmark
Immanuel Klinik Rudersdorf
Rüdersdorf, Brandenburg, 15562, Germany
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Marburg, Hesse, 35043, Germany
Katholisches Klinikum Bochum gGmbH
Bochum, North Rhine-Westphalia, 44791, Germany
Judisches Krankenhaus Berlin
Berlin, 13347, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2024
First Posted
August 5, 2024
Study Start
April 29, 2025
Primary Completion (Estimated)
August 17, 2027
Study Completion (Estimated)
August 17, 2027
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.