Vitaccess Real CIDP Registry

NCT07006597 | Not Yet Recruiting DMC

• 1 other identifier: 5166-Vitaccess-CIDP-01
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• The Vitaccess Real CIDP Registry

  A patient registry designed to build a repository of data containing disease characteristics at onset, disease progression, treatment and outcomes in CIDP \[(i.e., its treatment and impact on symptoms, daily activities, and quality of life (QoL)\] from patients, HCPs, and existing medical records.

  10 years

Secondary Outcomes (25)

• Describe the demographic characteristics of patients

  At baseline

• Describe the change in clinical trial participation of patients

  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

  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

  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

  At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Vitaccess Ltd: lead

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Nervous System Diseases; Autoimmune Diseases; Neurodegenerative Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mark JW Larkin, PhD

CONTACT

+44 1865818983; mark.larkin@vitaccess.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mark JW Larkin, PhD,Vitaccess Ltd

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 1, 2035
• Study Completion (Estimated): July 1, 2035
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share