Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)HYbISCUENCT06538064
A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), run by Takeda at 15 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- How many people
- 30 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 29 Apr 2025to 17 Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
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- 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].
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 3 countries
United States9 sites, 9 recruiting
- Recruiting
Nova Clinical Research, LLC
Bradenton, Florida, 34209
Site Contact, 941-792-6564, sanjay.yathiraj@novaclinicalresearch.com
Sanjay Yathiraj
- Recruiting
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
Site Contact, 808-564-6141, kliow@hawaiineuroscience.com
Kore Liow
- Recruiting
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
Site Contact, 913-588-6922, mpasnoor@kumc.edu
Mamatha Pasnoor
- Not yet recruiting
Yale School Of Medicine
New Haven, Connecticut, 06510
Site Contact, 203-785-4085, bhaskar.roy@yale.edu
Bhaskar Roy
- Recruiting
HSHS St. Elizabeths Hospital
O'Fallon, Illinois, 62269
Site Contact, 618-641-5803, raghav.govindarajan@hshs.org
Raghav Govindarajan
- Recruiting
Samir Macwan MD Inc
Rancho Mirage, California, 92270
Site Contact, 760-531-4068, smacwan@southlandneuromuscular.com
Samir Macwan
- Recruiting
Neuro/Psych Sleep Clinic
San Francisco, California, 94143
Site Contact, 415-353-2273, pritikanta.paul@ucsf.edu
Pritikanta Paul
- Not yet recruiting
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33713
Site Contact, 727-202-2623, abvmd@aol.com
Alberto Vasquez
- Recruiting
Wake Forest University - School of Medicine - Central
Winston-Salem, North Carolina, 27157
Site Contact, 336-716-2357, rgandhi@wakehealth.edu
Rachana Gandhi Mehta
Germany4 sites, 4 recruiting
- Not yet recruiting
Judisches Krankenhaus Berlin
Berlin, 13347
Site Contact, +493049942658, juliane.klehmet@jkb-online.de
Juliane Klehmet
- Recruiting
Katholisches Klinikum Bochum gGmbH
Bochum, North Rhine-Westphalia, 44791
Site Contact, +492345092411, kalliopi.pitarokoili@ruhr-uni-bochum.de
Kalliopi Pitarokoili
- Not yet recruiting
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Marburg, Hesse, 35043
Site Contact, +491064215865226, seipelt@med.uni-marburg.de
Maria Seipelt
- Recruiting
Immanuel Klinik Rudersdorf
Rüdersdorf, Brandenburg, 15562
Site Contact, +493363883347, jens.schmidt@mhb-fontane.de
Jens Schmidt
Denmark2 sites, 2 recruiting
- Recruiting
Arhus Universtitetshospital
Aarhus N, 8200
Site Contact, +4578463337 0000000 0000, larsmark@rm.dk
Lars Markvardsen
- Recruiting
Rigshospitalet
København Ø, 2100
Site Contact, +4522981147, ali.al-zuhairy@regionh.dk
Ali Al-Zuhairy
About this study
Official title: A Global Real-World Study to Assess HyQvia Use and Outcomes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Switching to HyQvia
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.
- Being tested
- No Intervention
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention | |
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, Month 6, Month 9, and Month 12 (as available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start29 Apr 2025
- Primary completion17 Aug 2027 (estimated)
- Study completion17 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538064
- Sponsor's protocol ID
- TAK-771-5008
- Other IDs
- 2024-512690-26-00
- Acronym
- HYbISCUE
- Status last verified
- Nov 2025
- First submitted
- 31 Jul 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.