Evaluating the effects of ravulizumab in patients with neuromyelitis optica spectrum disorder
Clinical and Radiological Outcomes in People With Aquaporin-4 IgG Positive Neuromyelitis Optica Spectrum Disorder Treated With Ravulizumab
This study is testing if the medication ravulizumab can help people with neuromyelitis optica spectrum disorder feel better and improve their MRI results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | ravulizumab, eculizumab |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06398158 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical and radiological effects of ravulizumab in individuals diagnosed with aquaporin-4 IgG positive neuromyelitis optica spectrum disorder. Participants will be treated with ravulizumab as per FDA guidelines, and their clinical performance will be compared to their pre-treatment status. The study will also investigate conventional MRI outcomes and identify biomarkers related to disease activity. A total of 35 participants will be recruited from The University of Texas Southwestern Medical Center in Dallas, Texas.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are aquaporin-4 IgG positive and are being treated with ravulizumab.
Not a fit: Patients who are intolerant to MRI or have previously been treated with eculizumab without effective disease control may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies and improve outcomes for patients with neuromyelitis optica spectrum disorder.
How similar studies have performed: While this study focuses on a specific treatment and condition, similar studies have shown promise in evaluating the effects of monoclonal antibodies in neuromyelitis optica.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed informed consent available prior to conduct of any study associated activities 2. Men and women \> 18 years of age 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. Expanded Disability Status Scale score of \<7.0 Exclusion Criteria: 1. Individuals who are intolerant to MRI 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. Unresolved meningococcal disease 4. History of an active infection 5. Existing participation in neuromyelitis optical spectrum disorder interventional clinical studies 6. Pregnant or lactating women
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Darin T. Okuda, MD — University of Texas Southwestern Medical Center
- Study coordinator: Diem Tran, PhD
- Email: diemh.tran@utsouthwestern.edu
- Phone: 214-645-9165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.