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Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

A Randomized Controlled, Open-Label, Rater-Blinded Pragmatic Trial, Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

NCT07100990•Mayo Clinic

View on ClinicalTrials.gov

Summary

The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Study Population and Setting
•≥18 years of age
•MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis
•Visual acuity 20/200 or worse
•Within 8 days of onset of visual symptoms
•Able to initiate PLEX within 72h of the first dose of HDCS (if randomized to the "Early PLEX" treatment arm)
•Able to sign and date informed consent form
•Willingness to comply with all study procedures and availability for the duration of the study
•≥18 years of age
•Diagnosis of Transverse Myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group; ALL are required)
+10 more criteria

Exclusion Criteria

•Optic Neuritis Sub-Trial:
•Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation)
•Ophthalmological comorbidity that would significantly affect best corrected visual acuity or visual fields
•Pregnancy
•Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis.
•Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and/or medical comorbidity)
•Treatment with any investigational agent within 6 months of baseline or five half-lives of the investigational agent (whichever is longer)
•Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including:
•* Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization
•* Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization
+25 more criteria

Locations (24)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

University of Colorado - Anschutz Medical

Aurora, Colorado, United States

Yale University School of Medicine

North Haven, Connecticut, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

University of Illinois Chicago

Chicago, Illinois, United States

Northwestern University

Evanston, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Harvard University Massachusetts General Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

July 11, 2025

Primary Completion Date

April 1, 2029

Completion Date

April 30, 2031

Last Updated

March 11, 2026

Enrollment

382

ESTIMATED participants

Conditions

Optic NeuritisMyelitisMyelitis, Transverse

Interventions

High-dose corticosteroids (HDCS)

DRUG

High-dose corticosteroids (HDCS) and PLEX

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

Inclusion Criteria

Exclusion Criteria

Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study

Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies

The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders

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French Registry for Monitoring Pregnancies for Multiple Sclerosis