NCT05734404

Brief 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. The purpose of this study is to establish a research cohort to investigate the disease process, treatments, and patient outcomes in CNSV.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
56mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Mar 2023Dec 2030

First Submitted

Initial submission to the registry

February 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

7.8 years

First QC Date

February 8, 2023

Last Update Submit

January 21, 2026

Conditions

Central Nervous System VasculitisCNS VasculitisCNSVVasculitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Study completion; from baseline through month 36.

Secondary Outcomes (8)

  • PROMIS Questionnaires

    Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36

  • PROMIS Questionnaires

    Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36

  • PROMIS Questionnaires

    Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36

  • PROMIS Questionnaires

    Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36

  • PROMIS Questionnaires

    Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • i. 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
  • ii. ≥18 years of age

You may not qualify if:

  • i. Unwilling to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

St. Joseph's Healthcare

Hamilton, Canada

RECRUITING

University of Toronto/Sinai Health

Toronto, Canada

RECRUITING

MeSH Terms

Conditions

Vasculitis, Central Nervous SystemVasculitis

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Rula Hajj-Ali, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Leonard Calabrese, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Peter Merkel, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol McAlear

CONTACT

7813214567cmcalear@upenn.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 21, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)CA(2)