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TIMELY-PLEX

Overview

About this study

A Randomized Controlled, Open-label, Rater-blinded Pragmatic trial, “Treatment of Inflammatory Myelitis and Optic Neuritis with Early vs Rescue Plasma Exchange (TIMELY-PLEX)”, comparing these two treatment strategies. 1) Plasma exchange (PLEX) is an established intervention that is commonly used in clinical practice in the United States for the treatment of severe optic neuritis (ON) and transverse myelitis (TM) 2) Based on the existing evidence and society guidelines/expert opinion, there is equipoise as to whether using early PLEX (concurrently with high dose corticosteroids [HDCS]) is associated with better neurological outcomes in ON and TM, as compared to a “traditional” treatment algorithm of initial HDCS followed by rescue PLEX in cases without significant improvement after HDCS 3) Both of these treatment approaches are healthcare options that are available and used in clinical practice in the United States, with an unclear risk-benefit and cost-benefit ratio, representing a challenge for providers, patients, and health systems. 

Patients will be recruited from 310 participating sites across the United States. The sites are from a diversity of geographic regions, serving diverse racial/ethnic populations and urban, suburban, and rural populations. A diverse patient population is not only important to increase the generalizability of the trial results, but also to ensure we capture patients with NMOSD, a condition that that appears to exhibit a preponderance for Black and Eastern Asian populations, and presents often with severe ON or TM.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Study Population and Setting

The proposal will recruit participants presenting to participating sites with severe ON or severe TM to two separate sub-trials. The detailed inclusion and exclusion criteria for each sub-trial are listed below:

Optic Neuritis Sub-Trial:

Inclusion criteria:

  • Patients ≥18 years of age
  • Severe optic neuritis (defined as visual acuity 20/200 or worse)
  • 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 
  • Within 8 days of onset of visual symptoms

Exclusion criteria:

  • On chronic immunotherapy at time of enrollment
  • Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation)
  • Ophthalmological comorbidity
  • Presence of any contraindication to receiving 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)

Transverse Myelitis Sub-Trial:

Inclusion criteria:

  • Patients ≥18 years of age
  • Diagnosis of transverse myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group)2
  • Expanded Disability Status Scale [EDSS] ≥4.0 (excluding visual and cerebral functional systems)
  • Within 8 days of onset of motor symptoms

 

Exclusion criteria:

  • On chronic immunotherapy at time of enrollment
  • Fulfillment of possible, probable or definite spinal cord infarction diagnosis per proposed diagnostic criteria120
  • Pre-existing ambulatory, motor, sensory, or bowel/bladder disability of any cause that could confound trial assessments
  • Presence of any contraindication to receiving 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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Chen, M.D., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Jessica Morgan C.O.A.

(507) 293-9689

Morgan.Jessica@mayo.edu

More information

Publications

Publications are currently not available

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