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

Korábbi kezelés

• 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.
• 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.

Más betegség

• Participants with known hypersensitivity to any component of HyQvia.

Egyéb

• Pregnant or breastfeeding.
• 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.

• 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].