Clinical trial NCT06538064: A Study of HyQvia in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) in Routine Clinical Care
Official title: A Global Real-World Study to Assess HyQvia Use and Outcomes in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Switching to HyQvia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is participants with a confirmed clinical diagnosis of CIDP, who are in the process of switching from any prior CIDP therapy to HyQvia for maintenance treatment of CIDP. The participants population will be comprised of both new users (Cohort A) and current users (Cohort B) of HyQvia.

Brief 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 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.

Primary outcomes:
measure: Treatment Preference for CIDP Therapy as Measured by Novel Treatment Preference Questionnaires
timeFrame: Baseline up to 12 months (HyQvia or study discontinuation)
measure: Treatment Satisfaction With HyQvia as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) Short Form-9
timeFrame: Baseline up to 12 months
measure: Health-Related Quality of Life (HRQoL) as Measured by the Chronic Acquired Polyneuropathy Patient Reported Index (CAP-PRI)
timeFrame: Baseline up to 12 months
measure: CIDP Signs, Symptoms, and Impacts, as Measured by the Inflammatory Rasch-built Overall Disability Scale (I-RODS)
timeFrame: Baseline up to 12 months (HyQvia or study discontinuation)
measure: Productivity as Measured by the Work Productivity and Activity Impairment (WPAI)
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs) and All Non-serious Adverse Events (AEs) Causally or Temporally Relationship to HyQvia Treatment
timeFrame: Baseline up to 12 months
measure: Number of Participants With Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Increase of >=1 point Relative to the Baseline
timeFrame: Baseline up to 12 months
measure: Change From Baseline in Adjusted INCAT Disability Score
timeFrame: Baseline up to 12 months
measure: Change From Baseline in Hand Grip Strength
timeFrame: Baseline up to 12 months
measure: Change from Baseline in Medical Research Council (MRC) Score
timeFrame: Baseline up to 12 months
measure: Change From Baseline in I-RODS Centile Score
timeFrame: Baseline up to 12 months
measure: Treatment Utilization of HyQvia
timeFrame: Baseline, Month 3, Month 6, Month 9, and Month 12 (as available)
measure: Healthcare Resource Utilization (HCRU)
timeFrame: Baseline, Month 3, Month 6, Month 9, and Month 12 (as available)
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Neurology Specialty Clinic
state: California
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: