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

Официальное название

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

Обзор

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.

Вмешательства

• Другое No Intervention
  This is a non-interventional study.

Первичные конечные точки

• Treatment Preference for CIDP Therapy as Measured by Novel Treatment Preference Questionnaires [Срок оценки: Baseline up to 12 months (HyQvia or study discontinuation)]
• Treatment Satisfaction With HyQvia as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) Short Form-9 [Срок оценки: Baseline up to 12 months]
• Health-Related Quality of Life (HRQoL) as Measured by the Chronic Acquired Polyneuropathy Patient Reported Index (CAP-PRI) [Срок оценки: Baseline up to 12 months]
• CIDP Signs, Symptoms, and Impacts, as Measured by the Inflammatory Rasch-built Overall Disability Scale (I-RODS) [Срок оценки: Baseline up to 12 months (HyQvia or study discontinuation)]
• Productivity as Measured by the Work Productivity and Activity Impairment (WPAI) [Срок оценки: Baseline up to 12 months]

Вторичные конечные точки (8)

• Number of Participants With Serious Adverse Events (SAEs) and All Non-serious Adverse Events (AEs) Causally or Temporally Relationship to HyQvia Treatment [Срок оценки: Baseline up to 12 months]
• Number of Participants With Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Increase of >=1 point Relative to the Baseline [Срок оценки: Baseline up to 12 months]
• Change From Baseline in Adjusted INCAT Disability Score [Срок оценки: Baseline up to 12 months]
• Change From Baseline in Hand Grip Strength [Срок оценки: Baseline up to 12 months]
• Change from Baseline in Medical Research Council (MRC) Score [Срок оценки: Baseline up to 12 months]
• Change From Baseline in I-RODS Centile Score [Срок оценки: Baseline up to 12 months]
• Treatment Utilization of HyQvia [Срок оценки: Baseline, Month 3, Month 6, Month 9, and Month 12 (as available)]
• Healthcare Resource Utilization (HCRU) [Срок оценки: Baseline, Month 3, Month 6, Month 9, and Month 12 (as available)]

Критерии участия

Критерии включения

• 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 \[sub-study\].

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 9 центров

• Samir Macwan MD Inc — Rancho Mirage
• Neuro/Psych Sleep Clinic — San Francisco
• Yale School Of Medicine — New Haven
• Nova Clinical Research, LLC — Bradenton
• Suncoast Neuroscience Associates, Inc. — St. Petersburg
• Hawaii Pacific Neuroscience — Honolulu
• HSHS St. Elizabeths Hospital — O'Fallon
• University of Kansas Medical Center Research Institute, Inc. — Kansas City
• … и ещё 1 центр

Германия · 4 центра

• Immanuel Klinik Rudersdorf — Rüdersdorf
• Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg — Marburg
• Katholisches Klinikum Bochum gGmbH — Bochum
• Judisches Krankenhaus Berlin — Berlin

Дания · 2 центра

• Arhus Universtitetshospital — Aarhus N
• Rigshospitalet — København Ø

Идентификаторы

NCT: NCT06538064 · TAK-771-5008 · 2024-512690-26-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗