Central Nervous System VasculitisNCT05734404
Longitudinal Study for Central Nervous System Vasculitis
An observational study of Central Nervous System Vasculitis and CNS Vasculitis, run by University of Pennsylvania at 6 sites in 2 countries.
Trial summary
Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Vasculitis, CNS Vasculitis, CNSV
- How many people
- 40 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Mar 2023to 31 Dec 2030
- 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: Individuals with central nervous system vasculitis (CNSV). Enrollment will be sequential and participants will have disease in various stages and of different duration.
Who may be able to join
- Diagnostic criteria for CNSV
- The presence of an acquired and otherwise unexplained neurologic deficit
- The presence of either classic angiographic or histopathologic features of angiitis in the CNS
- No evidence of systemic vasculitis or any condition that could cause the angiographic or pathologic features
- ≥18 years of age
Who cannot join
- Unwilling to sign informed consent.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Brittany McKnight, mcknigb@ccf.org
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37232
Pamela Schlairet, pamela.schlairet@vumc.org
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jessica Nguyen, Jessica.Nguyen2@PennMedicine.upenn.edu
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jenni Sletten, Sletten.Jennifer@mayo.edu
Canada2 sites, 2 recruiting
- Recruiting
St. Joseph's Healthcare
Hamilton
Sandra Messier, smessier@stjosham.on.ca
- Recruiting
University of Toronto/Sinai Health
Toronto
Nazrana Haq, Nazrana.Haq@sinaihealth.ca
About this study
Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. The purpose of this study is to establish a research cohort to investigate the disease process, treatments, and patient outcomes in CNSV.
Read the detailed description
Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. Originally described in the early 1950s, research in the disease has been slow to progress, largely limited by the rarity of the disease and the lack of biologic materials for basic and translational investigations. To date, the bulk of research in the field has been clinical, largely consisting of retrospective case series, predominately from single sites, focusing on correlations among clinical, imaging, and histopathology data. Collectively these series suggest the existence of clinically-relevant subsets. Such studies, while enhancing our knowledge of this rare disease, are limited by small numbers of patients (especially those confirmed by histopathology), and the near absence of detailed investigations into the biomolecular and immunopathogenic basis of the disease.
Development of this longitudinal cohort and multicenter approach offers the potential to generate new insights, generate new questions, and further our understanding of its natural history, pathophysiology, genetic basis, and discovery of biomarkers to assess disease activity and prognosis.
Study visits will occur every 3 months for this first year, and then annually for two more years. Blood collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.
- Conditions
- Central Nervous System Vasculitis, CNS Vasculitis, CNSV, Vasculitis
- Medical subject headings
- Vasculitis, Central Nervous System, Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the pathogenesis of central nervous system vasculitis using disease history.
To study the manner of development of disease in patients affected with central nervous system vasculitis.
Measured: Study completion; from baseline through month 36.
Secondary outcomes (8)
PROMIS Questionnaires
Questions will ask about Cognition function on the PROMIS short form.
Measured: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about depression on the PROMIS short form.
Measured: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about fatigue on the PROMIS short form.
Measured: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about Ability to participate in social roles and activities on the PROMIS short form.
Measured: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about Upper extremity function on the PROMIS short form.
Measured: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about lower extremity function on the PROMIS short form.
Measured: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about Global Health (physical) on the PROMIS short form.
Measured: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Questions will ask about Global Health (mental) on the PROMIS short form.
Measured: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System VasculitisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Rula Hajj-Ali, MD, Principal investigator, The Cleveland ClinicLeonard Calabrese, MD, Principal investigator, The Cleveland ClinicPeter Merkel, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734404
- Sponsor's protocol ID
- VCRC5509
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study for Central Nervous System Vasculitis
- ClinicalTrials.gov ID
- NCT05734404
- Acronym / sponsor ID
- VCRC5509
- Conditions
- Central Nervous System Vasculitis, CNS Vasculitis, CNSV, Vasculitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Feb 2023 (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.
Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. The purpose of this study is to establish a research cohort to investigate the disease process, treatments, and patient outcomes in CNSV.
Detailed description
Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. Originally described in the early 1950s, research in the disease has been slow to progress, largely limited by the rarity of the disease and the lack of biologic materials for basic and translational investigations. To date, the bulk of research in the field has been clinical, largely consisting of retrospective case series, predominately from single sites, focusing on correlations among clinical, imaging, and histopathology data. Collectively these series suggest the existence of clinically-relevant subsets. Such studies, while enhancing our knowledge of this rare disease, are limited by small numbers of patients (especially those confirmed by histopathology), and the near absence of detailed investigations into the biomolecular and immunopathogenic basis of the disease.
Development of this longitudinal cohort and multicenter approach offers the potential to generate new insights, generate new questions, and further our understanding of its natural history, pathophysiology, genetic basis, and discovery of biomarkers to assess disease activity and prognosis.
Study visits will occur every 3 months for this first year, and then annually for two more years. Blood collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with central nervous system vasculitis (CNSV). Enrollment will be sequential and participants will have disease in various stages and of different duration.
Key inclusion criteria (5 listed)
- Diagnostic criteria for CNSV
- The presence of an acquired and otherwise unexplained neurologic deficit
- The presence of either classic angiographic or histopathologic features of angiitis in the CNS
- No evidence of systemic vasculitis or any condition that could cause the angiographic or pathologic features
- ≥18 years of age
Key exclusion criteria (1 listed)
- Unwilling to sign informed consent.
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
Evaluate the pathogenesis of central nervous system vasculitis using disease history.
Time frame: Study completion; from baseline through month 36.
To study the manner of development of disease in patients affected with central nervous system vasculitis.
8 secondary outcomes
PROMIS Questionnaires
Time frame: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
PROMIS Questionnaires
Time frame: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36
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 23 Jan 2026.
- 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.
Rula Hajj-Ali, MD principal investigator
The Cleveland Clinic
Leonard Calabrese, MD principal investigator
The Cleveland Clinic
Peter Merkel, MD principal investigator
University of Pennsylvania
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Vasculitis and CNS Vasculitis, run by University of Pennsylvania at 6 sites in 2 countries.
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 5 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Carol McAlear (7813214567, cmcalear@upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the pathogenesis of central nervous system vasculitis using disease history. (time frame: Study completion; from baseline through month 36.). 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 23 Jan 2026.