RECRUITING

A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care

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Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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). 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.

Official Title

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

Quick Facts

Study Start:2025-04-29
Study Completion:2027-08-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants aged 18 years or older.
  2. * 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.
  3. * Participants must currently have a stable disease course (as per physician judgment) for at least 12 weeks.
  4. * Is considered a new user or current user of HyQvia-
  5. * 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.
  6. * 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).
  7. * Has provided written informed consent (for the main study).
  8. * 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).
  9. * Participants must be able to communicate fluently in their local language (if they participate in the optional qualitative participant interview \[sub-study\].
  1. * Had any HyQvia use, defined as
  2. * any record of HyQvia use prior to enrollment for new users of HyQvia (Cohort A), and
  3. * 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).
  4. * Without any prior treatment for CIDP.
  5. * Pregnant or breastfeeding.
  6. * Participants with known hypersensitivity to any component of HyQvia.
  7. * 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.
  8. * 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.
  9. * Received induction treatment for CIDP during the past 12 weeks.
  10. * Participant is identified by the investigator as being unable or unwilling to cooperate with the study procedures.
  11. * (Cohort A) only: Participants who do not initiate HyQvia treatment within 6 weeks after enrollment.

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

Eisenhower Neurology Specialty Clinic
Rancho Mirage, California, 92270
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29
Study Completion Date2027-08-17

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2027-08-17

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)