Vitaccess Real CIDP Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVitaccess Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
10 yearsSecondary outcomes
1
Describe the demographic characteristics of patients
EMR data reported by HCPs or captured via EMR aggregators ("Registration Form")
Time frame
At baseline2
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 years3
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 years4
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 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: