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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 \[sub-study\].

Locations
United States
California
Samir Macwan MD Inc
RECRUITING
Rancho Mirage
Neuro/Psych Sleep Clinic
RECRUITING
San Francisco
Connecticut
Yale School Of Medicine
NOT_YET_RECRUITING
New Haven
Florida
Nova Clinical Research, LLC
RECRUITING
Bradenton
Suncoast Neuroscience Associates, Inc.
NOT_YET_RECRUITING
St. Petersburg
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Illinois
HSHS St. Elizabeths Hospital
RECRUITING
O'fallon
Kansas
University of Kansas Medical Center Research Institute, Inc.
RECRUITING
Kansas City
North Carolina
Wake Forest University - School of Medicine - Central
RECRUITING
Winston-salem
Other Locations
Denmark
Arhus Universtitetshospital
RECRUITING
Aarhus N
Rigshospitalet
RECRUITING
København Ø
Germany
Judisches Krankenhaus Berlin
NOT_YET_RECRUITING
Berlin
Katholisches Klinikum Bochum gGmbH
RECRUITING
Bochum
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
NOT_YET_RECRUITING
Marburg
Immanuel Klinik Rudersdorf
RECRUITING
Rüdersdorf
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2027-08-17
Participants
Target number of participants: 30
Treatments
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.
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.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov