Observes adults with CIDP switching to HyQvia in routine care
Follows adults with CIDP who switch to HyQvia during routine treatment.
Plain-language title generated from the registry record
Registry title: A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care
Key facts
- Where
- Aarhus N and København Ø, DenmarkSee the 2 sites
Where in Denmark
- Arhus UniverstitetshospitalAarhus N, DenmarkTaking people
- RigshospitaletKøbenhavn Ø, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Takeda
- Trial code
- NCT06538064EU 2024-512690-26-00
- Record updated
- 21 November 2025
- Original description
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).Read full original descriptionShow less
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.
Inclusion: 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].
Exclusion: 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; 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; Participants with known hypersensitivity to any component of HyQvia; Pregnant or breastfeeding; 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.