Vitaccess Real CIDP Registry

Traditional site recruitment (all countries):

Adult patients who are being treated for CIDP at one of the participating clinics or centers in one of the participating countries (the US, UK or Germany) at the time of enrolment and who meet the inclusion and exclusion criteria will be identified, approached by their clinical team and invited to participate in the registry.

Patient-reported data will be collected via the VRCIDP Registry platform, a digital data capture platform accessible via a web-enabled platform on a connected device (e.g., smartphone, tablet, laptop, computer). Custom survey and patient-reported outcomes data will be collected at baseline and at regular intervals thereafter for a follow-up period of up to 10 years. The data collected will capture the impact of CIDP on daily living, fatigue, and health-related quality of life.

Site research teams will complete and update an electronic case report form (eCRF every six months ± one month for each patient, including data from the patient's EMR. eCRFs that are completed within one months prior to or following each six-month period will be considered within the same assessment window for analytics purposes. This ensures that patients will not be required to visit the clinical site for the purposes of the registry outside of their regular clinical visits.

Community neurologist recruitment (US only):

Community neurologists who are treating CIDP patients who would be eligible for participation in the registry will be able to register their interest for involvement and provide details of their credentials via an informational website. Approved community neurologists will identify and approach potential participants, who will participate in the registry as normal. Vitaccess will partner with a third-party organization with EMR aggregator capabilities to capture data from participants' existing medical records to match eCRF outputs.

Direct-to-patient recruitment (US only):

The direct-to-patient recruitment approach will involve patients directly registering their interest for participating in the registry. Awareness of the study will be raised via collaborations with patient advisory group(s) (PAGs), who may utilize their existing relationships with CIDP patients to inform them of the study, for example via their social media. Likewise, Vitaccess may utilize social media to advertise the study directly to patients. Recruitment/promotional materials will be created for the purpose of sharing on social media platforms. As with recruitment via community neurologists, existing EMR data will be captured for consenting participants by a third-party organization with EMR aggregator capabilities.

• Describe the demographic characteristics of patients [Time frame: At baseline]
• Describe the change in clinical trial participation of patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe the diagnosis (date, test, symptoms) of patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe the change in clinical characteristics of patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe the change in medical history of patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe the change in concomitant treatments received by patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe the change in routine CIDP treatments received by patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in rescue CIDP treatments received by patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe the change in healthcare resource use of patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in type and severity of adverse events experienced by patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe change in caregiver requirements experienced by patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]
• Describe the family history of patients [Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years]