RECRUITING

Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an observational study to: * evaluate the on-treatment clinical performance of ravulizumab in relation to the pre-treatment time period (time period prior to exposure), * enhance knowledge regarding conventional MRI outcomes in people with NMOSD treated with ravulizumab, * identify factors suggestive of subclinical disease progression through conventional MRI sequences, * determine if treatment with ravulizumab, impacts longitudinal 3D conformational MRI measures at the dorsal medulla and other regions of the CNS, and * identify biomarkers (e.g., serum neurofilament light chain (sNfL), conventional and novel MRI markers, etc.) related to disease activity.

Official Title

Clinical and Radiological Outcomes in People With Aquaporin-4 IgG Positive Neuromyelitis Optica Spectrum Disorder Treated With Ravulizumab

Quick Facts

Study Start:2024-07-10
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06398158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Signed informed consent available prior to conduct of any study associated activities
  2. 2. Men and women \> 18 years of age
  3. 3. Aquaporin-4 IgG positive people with neuromyelitis optica spectrum disorder treated with commercially available ravulizumab in a manner consistent with the approved indication
  4. 4. Expanded Disability Status Scale score of \<7.0
  1. 1. Individuals who are intolerant to MRI
  2. 2. Individuals previously exposed to eculizumab with treatment discontinuation due to lack of effective disease control (i.e., clinical relapse or demonstration of MRI advancement after 12 weeks of sustained treatment exposure)
  3. 3. Unresolved meningococcal disease
  4. 4. History of an active infection
  5. 5. Existing participation in neuromyelitis optical spectrum disorder interventional clinical studies
  6. 6. Pregnant or lactating women

Contacts and Locations

Study Contact

Cindy Daniel
CONTACT
214-645-9165
cindy.daniel@utsouthwestern.edu
Francisco Villalobos
CONTACT
214-645-1878
francisco.villalobos@utsouthwestern.edu

Principal Investigator

Darin T. Okuda, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Peter Sguigna, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Darin T. Okuda, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center
  • Peter Sguigna, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-10
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Neuromyelitis Optica