Understanding the use of HyQvia in adults with CIDP

A Global Real-World Study to Assess HyQvia Use and Outcomes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Switching to HyQvia

This study looks at why adults with CIDP choose HyQvia for treatment and how it affects their satisfaction, daily life, and work productivity.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Takeda (industry)
• Locations: 15 sites (Rancho Mirage, California and 14 other locations)
• Trial ID: NCT06538064 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather insights on why adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) choose HyQvia as a treatment, including their satisfaction levels and the impact on their daily activities and work productivity. Data will be collected through medical records, participant interviews at the start and completion of the study, and questionnaires. The study will also assess the effectiveness of HyQvia and any side effects experienced during treatment, as well as the need for healthcare interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of CIDP who are either new users planning to switch to HyQvia or current users of HyQvia.

Not a fit: Patients with unstable CIDP or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of HyQvia's effectiveness and patient satisfaction, leading to improved treatment strategies for CIDP.

How similar studies have performed: While this study focuses on observational data, similar studies have shown promise in understanding treatment satisfaction and effectiveness in chronic conditions.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Rancho Mirage, California and 14 other locations

• Samir Macwan MD Inc — Rancho Mirage, California, United States (RECRUITING)
• Neuro/Psych Sleep Clinic — San Francisco, California, United States (RECRUITING)
• Yale School Of Medicine — New Haven, Connecticut, United States (NOT_YET_RECRUITING)
• Nova Clinical Research, LLC — Bradenton, Florida, United States (RECRUITING)
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States (NOT_YET_RECRUITING)
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States (RECRUITING)
• HSHS St. Elizabeths Hospital — O'Fallon, Illinois, United States (RECRUITING)
• University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States (RECRUITING)
• Wake Forest University - School of Medicine - Central — Winston-Salem, North Carolina, United States (RECRUITING)
• Arhus Universtitetshospital — Aarhus N, Denmark (RECRUITING)
• Rigshospitalet — København Ø, Denmark (RECRUITING)
• Immanuel Klinik Rudersdorf — Rüdersdorf, Brandenburg, Germany (RECRUITING)
• Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg — Marburg, Hesse, Germany (NOT_YET_RECRUITING)
• Katholisches Klinikum Bochum gGmbH — Bochum, North Rhine-Westphalia, Germany (RECRUITING)
• Judisches Krankenhaus Berlin — Berlin, Germany (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Takeda Contact

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy