Chronic Inflammatory Demyelinating PolyneuropathyVRCIDPNCT07006597
Vitaccess Real CIDP Registry
An observational study of Chronic Inflammatory Demyelinating Polyneuropathy and CIDP, run by Vitaccess Ltd.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2025to Jul 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Vitaccess Real CIDP Registry: A Prospective International Observational Patient Registry in Chronic Inflammatory Demyelinating Polyneuropathy Linking Clinical and Patient-Reported Data
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.
Read the 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.
- Keywords
- patient registry, longitudinal observational data, patient-reported outcomes, Nervous System Disease, Autoimmune Disease, Neurodegenerative Disease, Immune System Disease, Nervous System Diseases
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Nervous System Diseases, Autoimmune Diseases, Neurodegenerative Diseases, Immune System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (25)
Describe the demographic characteristics of patients
EMR data reported by HCPs or captured via EMR aggregators ("Registration Form")
Measured: At baseline
Describe the change in clinical trial participation of patients
EMR data reported by HCPs or captured via EMR aggregators ("Clinical Trial Participation Form")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregators ("Diagnosis Information Form")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregators ("Clinical Characteristics Form")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregators ("Medical History Form")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregators ("Concomitant non-CIDP medications log")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregators ("Routine CIDP medication log")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregators ("Rescue CIDP Treatments Log")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregators ("Healthcare Resource Use")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregators ("Adverse Events Form")
Measured: 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
EMR data reported by HCPs or captured via EMR aggregators ("Caregiver Information Form")
Measured: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the family history of patients
EMR data reported by HCPs or captured via EMR aggregators ("Family History Form")
Measured: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the change in employment status of patients
EMR data reported by HCPs or captured via EMR aggregators ("Employment Status Form")
Measured: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the change in health insurance status and out-of-pocket costs experienced by patients
EMR data reported by HCPs or captured via EMR aggregators ("Health Insurance Status Form")
Measured: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the disease history of patients
EMR data reported by HCPs or captured via EMR aggregators ("Disease History")
Measured: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the clinical investigations performed by treating neurologists on patients
EMR data reported by HCPs or captured via EMR aggregators ("Clinical Investigations")
Measured: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the treatment decisions and rationale for treatment decisions made by treating neurologists
EMR data reported by HCPs or captured via EMR aggregators ("Management Decisions by Treating Neurologist", "Health System Implications on Treatment", "Patient Choice on Treatment Decisions", "Tools used for Therapeutic Decisions")
Measured: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the impact of CIDP on multiple life domains
"Chronic Acquired Polyneuropathy patient-reported index (CAP-PRI)" data reported by patients via the Vitaccess Real CIDP Registry platform
Measured: At baseline and every 6 months thereafter for up to 10 years.
Describe the impact of CIDP on work productivity and daily activities
"Work Productivity and Activity Impairment (WPAI)" data reported by patients via the Vitaccess Real CIDP Registry platform
Measured: At baseline and every 6 months thereafter for up to 10 years.
Describe the health-related quality of life (HRQoL) of patients
"EQ-5D-5-level version (EQ-5D-5L)" data reported by patients via the Vitaccess Real CIDP Registry platform
Measured: At baseline visit and every 3 months thereafter for up to 10 years.
Describe the fatigue levels of patients
"NeuroQoL Fatigue Short Form" data reported by patients via the Vitaccess Real CIDP Registry platform
Measured: At baseline visit and every 6 months thereafter for up to 10 years.
Describe the stress levels of patients
"Perceived Stress Fixed Form" data reported by patients via the Vitaccess Real CIDP Registry platform
Measured: At baseline visit and every 6 months thereafter for up to 10 years.
Describe the pain of patients
"PROMIS Neuropathic Pain Quality 5a" and "PROMIS Pain Intensity 3a" data reported by patients via the Vitaccess Real CIDP Registry platform
Measured: At baseline visit and every 6 months thereafter for up to 10 years.
Describe the impact of CIDP on mood
"Hospital Anxiety and Depression Scale (HADS)" data reported by patients via the Vitaccess Real CIDP Registry platform
Measured: At baseline visit and every 6 months thereafter for up to 10 years.
Describe the perceived change in CIDP since study start
"Patient global impression of change (PGIC)" data reported by patients via the Vitaccess Real CIDP Registry platform
Measured: At baseline visit and every 6 months thereafter for up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start31 Jul 2025 (estimated)
- Primary completionJul 2035 (estimated)
- Study completionJul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Vitaccess Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mark Larkin, Vitaccess Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006597
- Sponsor's protocol ID
- 5166-Vitaccess-CIDP-01
- Acronym
- VRCIDP
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitaccess Real CIDP Registry: A Prospective International Observational Patient Registry in Chronic Inflammatory Demyelinating Polyneuropathy Linking Clinical and Patient-Reported Data
- ClinicalTrials.gov ID
- NCT07006597
- Acronym / sponsor ID
- VRCIDP / 5166-Vitaccess-CIDP-01
- Keywords
- patient registry, longitudinal observational data, patient-reported outcomes, Nervous System Disease, Autoimmune Disease, Neurodegenerative Disease, Immune System Disease, Nervous System Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vitaccess LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- Jul 2035 (estimated)
- Study completion
- Jul 2035 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Vitaccess Real CIDP Registry
Time frame: 10 years
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.
25 secondary outcomes
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
Describe the change in employment status 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 health insurance status and out-of-pocket costs experienced by patients
Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the disease history of patients
Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the clinical investigations performed by treating neurologists on patients
Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the treatment decisions and rationale for treatment decisions made by treating neurologists
Time frame: At baseline visit and at follow-up visits (every 6±1 months) for up to 10 years
Describe the impact of CIDP on multiple life domains
Time frame: At baseline and every 6 months thereafter for up to 10 years.
Describe the impact of CIDP on work productivity and daily activities
Time frame: At baseline and every 6 months thereafter for up to 10 years.
Describe the health-related quality of life (HRQoL) of patients
Time frame: At baseline visit and every 3 months thereafter for up to 10 years.
Describe the fatigue levels of patients
Time frame: At baseline visit and every 6 months thereafter for up to 10 years.
Describe the stress levels of patients
Time frame: At baseline visit and every 6 months thereafter for up to 10 years.
Describe the pain of patients
Time frame: At baseline visit and every 6 months thereafter for up to 10 years.
Describe the impact of CIDP on mood
Time frame: At baseline visit and every 6 months thereafter for up to 10 years.
Describe the perceived change in CIDP since study start
Time frame: At baseline visit and every 6 months thereafter for up to 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Demyelinating Polyneuropathy and CIDP, run by Vitaccess Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark JW Larkin, PhD (+44 1865818983, mark.larkin@vitaccess.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Vitaccess Real CIDP Registry (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.