An observational study in Chronic Inflammatory Demyelinating Polyneuropathy and CIDP, sponsored by Vitaccess Ltd. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by Vitaccess Ltd · Observational
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.
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.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
This study's planned enrollment of 300 is above the median of 49 across 44 observational studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →Vitaccess Ltd is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 10 years
Describe the demographic characteristics of patients
EMR data reported by HCPs or captured via EMR aggregators ("Registration Form")
Time frame: 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")
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
EMR data reported by HCPs or captured via EMR aggregators ("Diagnosis Information Form")
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
EMR data reported by HCPs or captured via EMR aggregators ("Clinical Characteristics Form")
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
EMR data reported by HCPs or captured via EMR aggregators ("Medical History Form")
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
EMR data reported by HCPs or captured via EMR aggregators ("Concomitant non-CIDP medications log")
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
EMR data reported by HCPs or captured via EMR aggregators ("Routine CIDP medication log")
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
EMR data reported by HCPs or captured via EMR aggregators ("Rescue CIDP Treatments Log")
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
EMR data reported by HCPs or captured via EMR aggregators ("Healthcare Resource Use")
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
EMR data reported by HCPs or captured via EMR aggregators ("Adverse Events Form")
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
EMR data reported by HCPs or captured via EMR aggregators ("Caregiver Information Form")
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
EMR data reported by HCPs or captured via EMR aggregators ("Family History Form")
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
EMR data reported by HCPs or captured via EMR aggregators ("Employment Status Form")
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
EMR data reported by HCPs or captured via EMR aggregators ("Health Insurance Status Form")
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
EMR data reported by HCPs or captured via EMR aggregators ("Disease History")
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
EMR data reported by HCPs or captured via EMR aggregators ("Clinical Investigations")
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
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")
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
"Chronic Acquired Polyneuropathy patient-reported index (CAP-PRI)" data reported by patients via the Vitaccess Real CIDP Registry platform
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
"Work Productivity and Activity Impairment (WPAI)" data reported by patients via the Vitaccess Real CIDP Registry platform
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline visit and every 6 months thereafter for up to 10 years.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Jul 2035, 120 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →
Vitaccess Ltd