Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco 5391959, California 5332921 and other locations
Dates
study started
study ends around
Principal Investigator
by Pritikanta Paul

Description

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.

Official Title

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

Keywords

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • Neuro/Psych Sleep Clinic accepting new patients
    San Francisco 5391959 California 5332921 94143 United States
  • Samir Macwan MD Inc accepting new patients
    Rancho Mirage 5386015 California 5332921 92270 United States

Lead Scientist at UCSF

  • Pritikanta Paul
    Assistant Professor, Neurology, School of Medicine. Authored (or co-authored) 21 research publications. Research interests: Neuromuscular Medicine · Peripheral Nerve · Myositis · Myopathy · Amyotrophic Lateral Sclerosis · Muscular Dystrophy · Electromyography · Myasthenia Gravis

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT06538064
Study Type
Observational
Participants
Expecting 30 study participants
Last Updated