Clinical trial NCT07006597: Vitaccess Real CIDP Registry
Official title: Vitaccess Real CIDP Registry: A Prospective International Observational Patient Registry in Chronic Inflammatory Demyelinating Polyneuropathy Linking Clinical and Patient-Reported Data
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
CIDP
Keywords: patient registry
longitudinal observational data
patient-reported outcomes
Nervous System Disease
Autoimmune Disease
Neurodegenerative Disease
Immune System Disease
Nervous System Diseases
Lead sponsor: Vitaccess Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who are being treated for CIDP at one of the participating clinics or centers in one of the study countries (the US, UK or Germany) at the time of enrolment and who meet the inclusion and exclusion criteria will be identified and approached by their clinical team and invited to participate in the registry.

Adult patients in the US who are not being treated at a participating clinic will be able to enrol via their community neurologist or direct-to-patient recruitment.

Brief summary: Vitaccess Real CIDP (VRCIDP) is a patient registry designed to capture longitudinal observational data on chronic inflammatory demyelinating polyneuropathy (CIDP), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). The duration of the registry is 10 years from launch, and approximately 300 patients will be recruited in the US and Europe with no defined upper limit. The registry will link relevant patient- and healthcare professional (HCP)-reported data with clinical data from electronic medical records (EMR). Patient reported and eCRF data will be linked via a unique ID and PIN assigned to each participant at enrolment.

Patients will be recruited at clinical sites in all participating countries. In the US only, patients can additionally be recruited via community neurologists or direct-to-patient recruitment.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult (age ≥18 years) with a clinically confirmed diagnosis of CIDP by their treating neurologist
* Resident in the US, UK or Germany
* Access to a smartphone/tablet/computer/laptop
* Willing and able to provide informed consent in their local language to take part in the study

Exclusion Criteria:

None

Primary outcomes:
measure: The Vitaccess Real CIDP Registry
timeFrame: 10 years
Secondary outcomes:
measure: Describe the demographic characteristics of patients
timeFrame: At baseline
measure: Describe the change in clinical trial participation of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the diagnosis (date, test, symptoms) of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the change in clinical characteristics of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the change in medical history of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the change in concomitant treatments received by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the change in routine CIDP treatments received by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in rescue CIDP treatments received by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the change in healthcare resource use of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in type and severity of adverse events experienced by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe change in caregiver requirements experienced by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the family history of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the change in employment status of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the change in health insurance status and out-of-pocket costs experienced by patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the disease history of patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the clinical investigations performed by treating neurologists on patients
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the treatment decisions and rationale for treatment decisions made by treating neurologists
timeFrame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
measure: Describe the impact of CIDP on multiple life domains
timeFrame: At baseline and every 6 months thereafter for up to 10 years.
measure: Describe the impact of CIDP on work productivity and daily activities
timeFrame: At baseline and every 6 months thereafter for up to 10 years.
measure: Describe the health-related quality of life (HRQoL) of patients
timeFrame: At baseline visit and every 3 months thereafter for up to 10 years.
measure: Describe the fatigue levels of patients
timeFrame: At baseline visit and every 6 months thereafter for up to 10 years.
measure: Describe the stress levels of patients
timeFrame: At baseline visit and every 6 months thereafter for up to 10 years.
measure: Describe the pain of patients
timeFrame: At baseline visit and every 6 months thereafter for up to 10 years.
measure: Describe the impact of CIDP on mood
timeFrame: At baseline visit and every 6 months thereafter for up to 10 years.
measure: Describe the perceived change in CIDP since study start
timeFrame: At baseline visit and every 6 months thereafter for up to 10 years.
Other outcomes:
Locations:
Study officials:
References: